WEEK ENDING SEPTEMBER 1

PRODUCT Granulocytes-Platelets Pheresis.
CODE Unit Numbers: 49P45679, 49P45682, 49P45696, 49P45699, 49P45703.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Granulocytes, Pheresis, were distributed, labeled as Granulocytes-Platelets, Pheresis.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 12FF96806 and 12GT10633.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION North Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor with a history of aplastic anemia.

PRODUCT a) Fresh Frozen Plasma; b) Plasma, Cryoreduced; c) Cryoprecipitated AHF; d) Recovered Plasma.
CODE Unit Numbers: a) 049LJ41613; b) 049LJ42617; c) 049LJ42617; d) 049LJ40738.
MANUFACTURER American Red Cross Blood Services, Waco, Texas.
DISTRIBUTION Texas and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of Multiple Sclerosis.

PRODUCT Red Blood Cells.
CODE Unit #6675607.
MANUFACTURER LifeShare Blood Centers, Alexandria, Louisiana.
DISTRIBUTION Louisiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Numbers: a) 42K20999, 42R53134, 42FY06461; b) 42K20999, 42FY06461.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION Ohio.
QUANTITY a) 3 units; b) 2 units were distributed.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 49FF39275, 49FF39278, 49FF39279, 49LH43975, 49LH43976, 49LH43982, 49LH43983.
MANUFACTURER American Red Cross Blood Services, Waco, Texas.
DISTRIBUTION Texas.
QUANTITY 7 units were distributed.
REASON Blood products were mislabeled as CMV antibody negative.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 18216-8943 and 18218-2386.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Wyoming and Texas.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #12441-4823.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION New Mexico.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #20278-1994.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Tennessee and Mississippi.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #20279-4222 and 20281-2856.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Louisiana.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Platelets.
CODE Unit #20279-8852.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Louisiana.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation.

PRODUCT a) Platelets; b) Source Leukocytes.
CODE Unit #3587130.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION Texas and New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose recorded body temperature was questionable.

PRODUCT Red Blood Cells
CODE Unit #FJ27348.
MANUFACTURER Healthcare Provider Services, Inc., doing business as Rhode Island Blood Center, Providence, Rhode Island.
DISTRIBUTION Rhode Island.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose hemoglobin had not been documented.

PRODUCT Platelets, Pheresis.
CODE Unit #7484645.
MANUFACTURER Carter Blood Center, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that may have compromised the sterility of the unit.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Pheresis; c) Cryoprecipitated AHF; d) Fresh Frozen Plasma; e) Recovered Plasma.
CODE Unit Numbers: a) 15005-8329; b) 15007-5146 (two split units); c) 15005-8329; d) 15005-4631; e) 15005-8329.
MANUFACTURER Blood Systems, Inc., Midland, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas and California.
QUANTITY a) 1 unit; b) 2 split units; c) 1 unit; d) 1 unit; e) 1 unit.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit Numbers: a) 15005-4368, 15006-6847; b) 15005-4368; c) 15005-4368.
MANUFACTURER Blood Systems, Inc., Midland, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas and California.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT Components and Distribution Information System (CDIS) Stand Alone Blood Bank Software.
CODE All versions up to and including version 1.1.1.
MANUFACTURER Information Data Management, Inc., Rosemont, Illinois.
DISTRIBUTION South Carolina, Hawaii, Ohio, Indiana, New Jersey, Missouri, Illinois, Tennessee, Hong Kong, and the United Kingdom.
QUANTITY Installed in 10 centers.
REASON Blood bank software contains a defect that results in not all products produced from a donation receiving the special donation properties that are applicable to donation.

PRODUCT Recovered Plasma.
CODE Unit #4449701.
MANUFACTURER Suncoast Communities Blood Bank, Inc., (Sarasota Community Blood Blood Bank, Inc., Sarasota, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had a tattoo within 12 months of donation.

PRODUCT Platelets.
CODE Unit #4455230.
MANUFACTURER Suncoast Communities Blood Bank, Inc., (Sarasota Community Blood Bank, Inc.), Sarasota, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells, Apheresis (Bag 1).
CODE Unit #4474320.
MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota Community Blood Bank, Inc.), Sarasota, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product had a hematocrit that was below the acceptable level.

PRODUCT a) Cocklebur Allergenic Extract; b) Rough Pigweed Allergenic Extract; c) Yellow Dock Allergenic Extract; d) Lambs Quarter Allergenic Extract.
CODE Lot Numbers: a) A907091A; b) A906111A; c) A003242A; d) A805072B.
MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio.
DISTRIBUTION New York.
QUANTITY 1 30-ml vial of each component was distributed.
REASON Expiration dates were omitted from the labeling of four allergenic extracts.

PRODUCT Source Plasma.
CODE Unit Numbers: 1941V045A and 1941V140A.
MANUFACTURER Centeon Bio-Services, Inc., Fort Worth, Texas.
DISTRIBUTION Germany.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who had previously been deferred for a history of Lupus.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit Numbers: 11324-7452, 11324-7478, 11324-7488, 11324-7821, 11324-7828, 11324-7810.
MANUFACTURER Blood Systems, Inc., El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas and New Mexico.
QUANTITY 6 units were distributed.
REASON Blood products were stored at unacceptable temperatures.

PRODUCT Platelets.
CODE Unit #11323-3909.
MANUFACTURER Blood Systems, Inc., El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT Platelets.
CODE Unit #7719234.
MANUFACTURER Carter Blood Center, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT Platelets.
CODE Unit #7727484.
MANUFACTURER Carter Blood Center, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #11323-5196.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product failed the criteria for red blood cell recovery after leukoreduction.

PRODUCT Red Blood Cells.
CODE Unit #49J80373.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose arm inspection was not documented as being performed.

PRODUCT Platelets.
CODE Unit #D98-03178.
MANUFACTURER Beth Israel Deaconess Hospital, Boston, Massachusetts.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for HBsAg, confirmatory negative, and negative for anti-HBc.

PRODUCT Platelets.
CODE Unit #7694303.
MANUFACTURER Carter Blood Center, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT Platelets.
CODE Unit #7738904.
MANUFACTURER Carter Blood Center, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #12438-6614.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION New Mexico.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

WEEK ENDING SEPTEMBER 8

PRODUCT Cryoprecipitated AHF.
CODE Unit Numbers: 30GH51679 and 30GH51671.
MANFACTURER American Red Cross Blood Services, Ashley, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 2 units were distributed.
REASON Blood products corresponded to two units of red blood cells that were implicated in a transfusion reaction.

PRODUCT Source Plasma.
CODE Unit Numbers: WXP093MO, WXP563MO, USM411MO, USP122MO, USU176MO, USU456MO.
MANFACTURER Aventis Bio-Services, Inc. F.K.A. Centeon Bio-Services, Inc., Louisville, Kentucky (Collection Site).
RECALLED BY Aventis Central Testing Laboratory, Knoxville, Tennessee
DISTRIBUTION California and France.
QUANTITY 6 units were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #24KK00833.
MANFACTURER American Red Cross Blood Services, Louisville, Kentucky.
DISTRIBUTION Kentucky and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot indeterminate.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit Numbers: a) V67169, V80035, Y09064; b) V67169, V80035, Y09064.
MANFACTURER Aurora Area Blood Bank, Aurora, Illinois.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 3 units of each component were distributed.
REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus (HIV-1/2), but were collectedfrom a donor who previously tested repeatedly reactive for the antibody, Western Blot negative.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #40FX17257.
MANFACTURER American Red Cross Blood Services, Peoria, Illinois.
DISTRIBUTION Alabama.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was previously deferred at another donor center.

PRODUCT Source Plasma.
CODE Unit Numbers: G63407-076, G63719-076, G65542-076, and G66044-076.
MANFACTURER Alpha Therapeutic Corporation, Fayetteville, North Carolina.
DISTRIBUTION Spain.
QUANTITY 4 units were distributed.
REASON Blood products, which tested negative for the hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested reactive for HbsAg.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #53GN36428.
MANFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Lupron.

PRODUCT Platelets, Pheresis.
CODE Unit #53LT65902.
MANFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #7592305.
MANFACTURER Carter Blood Center, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets, Irradiated.
CODE Unit #M58361.
MANFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose suitability was not adequately determined.

PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma; d) Source Leukocytes.
CODE Unit Numbers: a) 53GN98918, 53T30027; b) 53GN98918; c) 53GN98918, 53T30027; d) 53T30027.
MANFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland and New Jersey.
QUANTITY a) 2 units; b) 1 unit; c) 2 units; d) 1 unit was distributed.
REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis C.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Fresh Frozen Plasma; d) Platelets; e) Buffy Coat; f) Recovered Plasma.
CODE Unit Numbers: a) W05988, W00780, KH17935; b) W04347; c) W05988, KH17935; d) W05988, W00780, KH17935; e) W04347; f) W04347, W00780.
MANFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia and Switzerland.
QUANTITY a) 3 units; b) 1 unit; c) 2 units; d) 3 units; e) 1 unit; f) 2 units were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis C.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
CODE Unit #KR26924.
MANFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis B.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland, Virginia, Pennsylvania, and District of Columbia.
QUANTITY a) 118 units; b) 13 units were distributed.
REASON Blood products were inappropriately collected in 450-ml collection sets.

PRODUCT Platelets, Pheresis.
CODE Unit #9015822.
MANFACTURER Medic Regional Blood Center, Knoxville, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

PRODUCT Platelets/Granulocytes, Irradiated.
CODE Unit #9019145.
MANFACTURER Medic Regional Blood Center, Knoxville, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with extended expiration dates.

PRODUCT Recovered Plasma.
CODE Unit Numbers: 30GH51679 and 30GH51671.
MANFACTURER American Red Cross Blood Services, Ashley, Pennsylvania.
DISTRIBUTION Switzerland.
QUANTITY 2 units were distributed.
REASON Blood products corresponded to two units of Red Blood Cells that were implicated in a transfusion reaction.

PRODUCT Red Blood Cells for Further Manufacture.
CODE Unit Numbers: 49FJ69617 and 49FJ72878.
MANFACTURER American Red Cross Blood Services, Wichita, Falls, Texas.
RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma
DISTRIBUTION Illinois and Michigan.
REASON Blood products were collected from a donor who lived in an area designated as endemic for malaria.

PRODUCT a) Platelets; b) Fresh Frozen Plasma.
CODE Unit #7733842.
MANFACTURER Carter Blood Center, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood products were prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT Cryoprecipitated AHF.
CODE Unit #7710990.
MANFACTURER Carter Blood Center, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT Red Blood Cells.
CODE Unit #T03926.
MANFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history of colitis, was distributed.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit Numbers: 49LG48792, 49LG48794, 49LG48795, 49LG48796, 49LG48797, 49LG48798, 49LG48799, 49LG48801,49LG48802, 49LG48803, 49LG48804, 49LG48805, 49LG48806, 49LG48807, 49LG48809, 49LG48810, 49LG48830, 49LG48831, 49LG48832, 49LG48833, 49LG48834, 49LG48837, 49LG48838, 49LG48839, 49LG48841, 49LG48843, 49LG48845, 49LG48847, 49LG48849, 49LG48852.
MANFACTURER American Red Cross Blood Services, Waco, Texas.
DISTRIBUTED Texas.
QUANTITY 30 units were distributed.
REASON Blood products were leukoreduced by filtration greater than five days past the time of collection.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit Numbers: 9004483 and 9004485.
MANFACTURER Medic Regional Blood Center, Knoxville, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended expiration dates.

WEEK ENDING SEPTEMBER 15

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF.
CODE Unit #9334252.
MANUFACTURER Medic Regional Blood Center, Knoxville, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who previously tested repeatedly reactive for anti HBc on two separate occasions.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #7430231.
MANUFACTURER Carter BloodCare, Bedford, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose health history screening was incomplete at the time of donation.

PRODUCT Red Blood Cells.
CODE Unit #0329001.
MANUFACTURER Community Blood Bank of Erie County, Erie, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product had an elevated ALT.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #GJ43396.
MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania.
DISTRIBUTION Pennsylvania and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Proscar.

PRODUCT Red Blood Cells.
CODE Unit #22405-7444.
MANUFACTURER United Blood Services, Las Vegas, Nevada.
RECALED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Red Blood Cells
CODE Unit #22408-3951.
MANUFACTURER United Blood Services, Las Vegas, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Platelets
CODE Unit Numbers: 16348-3042, 16348-3045, and 16348-3046.
MANUFACTURER Blood Systems, Inc., Jackson, Mississippi.
DISTRIBUTION Mississippi.
QUANTITY 3 unit were distributed.
REASON Blood products were manufactured from whole blood that was shipped under unacceptable temperatures.

PRODUCT Red Blood Cells.
CODE Unit #9335878.
MANUFACTURER Medic Regional Blood Center, Knoxville, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Whole Blood, Autologous.
CODE 21R55016 and 21R55017.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Oregon.
QUANTITY 2 units were distributed.
REASON Blood products were collected in expired blood collection sets.

PRODUCT Fresh Frozen Plasma.
CODE Unit #16345-8646.
MANUFACTURER Blood Systems, Inc., Jackson, Mississippi.
DISTRIBUTION Mississippi.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from whole blood with an extended collection time.

PRODUCT Allergenic extract, Candida albicans.
CODE Lot #F19K4841.
MANUFACTURER Hollister-Stier Laboratories, LLC, Spokane, Washington.
DISTRIBUTION Indiana, Arkansas, New Jersey, New York, South Carolina.
QUANTITY 12 vials were distributed.
REASON Allergenic extract was not labeled with an expiration date.

WEEK ENDING SEPTEMBER 22

PRODUCT a) Whole Blood; b) Red Blood Cells; c) Red Blood Cells Leukocytes Reduced; d) e) Platelets; f) Platelets Pheresis; g) Plasma; h) Plasma Pheresis; i) Cryoprecipitated AHF; j) Platelets for Manufacturing Non-Injectable Products; k) Red Blood Cells for Manufacturing Non-Injectables; l) Source Leukocytes; m) Recovered Plasma for Manufacturing Non-Injectables; n) Red Blood Cells for Manufacturing;
o) Recovered Plasma.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Illinois, Michigan, New Jersey, Ohio, Pennsylvania, California, Switzerland.
QUANTITY a) 15 units; b) 307 units; c) 10 units; d) 186 units; e) 18 units; f) 122 units; g) 15 units; h) 35 units; i) 15 units; j) 8 units; k) 6 units; l) 7 units; m) 19 units; n) 217 units were distributed.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from donors who previously tested repeatedly reactive for the antibody, Western Blot indeterminate.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #04H86512.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Massachusetts and Puerto Rico.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had traveled to a malarial endemic area.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #38L49351.
MANUFACTURER American Red Cross, Fort Wayne, Indiana.
DISTRIBUTION Indiana and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had viral hepatitis after age eleven.

PRODUCT Platelets.
CODE Unit #38K90067.
MANUFACTURER American Red Cross, Fort Wayne, Indiana.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor in which arm preparation was not performed or was performed inappropriately.

WEEK ENDING SEPTEMBER 29

PRODUCT Platelets.
CODE Unit Numbers: 13LG61788, 13FN46316, 13LG61785.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 3 units were distributed.
REASON Blood products were not tested for CMV antibodies, but were labeled CMV negative.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 38E74764 and 38FC35905.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
DISTRIBUTION Indiana.
QUANTITY 2 units were distributed.
REASON Blood products were not phenotyped for the Jka antigen were distributed for a patient with an anti-Jka.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Numbers: 13GZ32027 and 13GZ31389.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #04M88637.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION California and Massachusetts.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor in which arm preparation was not performed or was performed inappropriately.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit Numbers: 3346817 and 3348271.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 2 units were distributed.
REASON Red Blood Cells were leukoreduced by filtration greater than five days past the time of collection.

PRODUCT Red Blood Cells
CODE Unit #50LJ08814.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after receiving post donation information reporting a bacterial throat infection.

PRODUCT Platelet Pheresis, Leukocytes Reduced.
CODE Unit #3904531.
MANUFACTURER Florida Blood Services, Tampa, Florida.
RECALLED BY Florida Blood Services, St. Petersburg, Florida
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product had a high white blood cell count.

PRODUCT Platelets, Pheresis.
CODE Unit #3350069.
MANUFACTURER Florida Blood Services, Tampa, Florida.
RECALLED BY Florida Blood Services, St. Petersburg, Florida
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

PRODUCT Source Plasma.
CODE Unit Numbers: N-70388-036, G-13893-036, G-14625-036, G-15087-036, G-15554-036, G-15888-036, G-16657-036, G-16946-036, G-17594-036, G-17902-036, G-18587-036, G-50936-036, G-51476-036, G-51856-036, G-52442-036, G-52658-036, G-53261-036, G-53486-036, G-54188-036, G-54522-036, G-54908-036, G-55238-036, G-28423-036, G-28618-036, G-29399-036, G-62905-036, G-29637-036, G-30356-036.
MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, California.
DISTRIBUTION Tennessee, New Jersey, Germany, Italy.
QUANTITY 28 units were distributed.
REASON Blood products tested negative for anti-HIV-1/2, but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1/2.

PRODUCT Red Blood Cells.
CODE Unit #12FN46389.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product which tested repeatedly reactive for HBsAg was subjected to additional duplicate retesting and distributed.

PRODUCT Platelets.
CODE Unit #7987888.
MANUFACTURER South Florida Blood Banks, West Palm Beach, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for anti-HIV-1, but was collected from a donor who previously tested repeatedly reactive for anti-HIV.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit Numbers: 7158951 and 7155675.
MANUFACTURER Carter BloodCare, Bedford, Texas.
DISTRIBUTION Texas and California.
QUANTITY 2 units were distributed.
REASON Blood products tested negative for anti-HIV-1, but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1.

PRODUCT Platelets.
CODE Unit #13FN48766.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood with a discrepant collection time.

PRODUCT Red Blood Cells.
CODE Unit #7944019.
MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who received a tissue transplant (surgery) within a year of donation.

PRODUCT Platelets, Pheresis.
CODE Unit Numbers: 8123963 and 8123964 (split unit).
MANUFACTURER South Florida Blood Banks, West Palm Beach, Florida.
DISTRIBUTION Florida.
QUANTITY 2 units were distributed.
REASON Blood products were stored at unacceptable temperatures.