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Biologic recalls tagged "Donor screening problem"

Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 82 recalls Dates are when each recall was announced (how we date recalls).
Agency
Risk level
Status
Date
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1 recall that day

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99398

1 recall that day

American Red Cross Blood Svcs Red Blood Cells, Leukocytes Reduced

Red Blood Cells and Apheresis Red Blood Cells were collected from donors who reported travel to a malaria endemic area but were not assessed for residency.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

2 recalls that day

We Are Blood Red Blood Cells and Pooled Cryoprecipitated AHF

Red Blood Cells and Pooled Cryoprecipitated AHF were collected from a donor who had permanent make-up applied within three months of donation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor not tested for Chagas.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99245

1 recall that day

Carter BloodCare Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

1 recall that day

New York Blood Center Fresh Frozen Plasma and Red Blood Cells

The products were collected from donors who previously tested reactive for the antibody to Hepatitis B core antigen on more than one occasion.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

2 recalls that day

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor not tested for Chagas.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99011

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99010

3 recalls that day

Blood Bank of Hawaii Apheresis Red Blood Cells, Pooled Cryoprecipitated AHF and Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, collected from a donor who had a hepatitis exposure prior to donation, were distributed.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

ImpactLife Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced tested non-reactive for anti-HCV but were collected from a donor who previously tested repeatedly reactive.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99004

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99003

2 recalls that day

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had no hematocrit check performed during screening.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98960

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98956

1 recall that day

ImpactLife Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who answered "no" to reading educational materials.

Low risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98937

2 recalls that day

We Are Blood Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were collected from a donor who had taken aspirin within 72 hours of donation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Community Blood Center of the Ozarks Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

4 recalls that day

Blood Bank of Hawaii Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98904

Coastal Bend Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Suncoast Communities Blood Bank Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98882

Suncoast Communities Blood Bank Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor in a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98878

1 recall that day

Blood Bank of Hawaii Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor with travel history to a malarial endemic area but not assessed for residency.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98873

1 recall that day

LifeServe Blood Center Red Blood Cells, Leukocytes Reduced, Irradiated

Red Blood Cells, Leukocytes Reduced, Irradiated were collected from a donor who had traveled to an area endemic for malaria.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

3 recalls that day

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98846

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98845

LifeShare Blood Centers Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who lacked documentation of arm inspection.

Low risk, FDA, Ended, Hospital use, Donor screening problem

2 recalls that day

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who traveled and lived in a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98936

ImpactLife PF24RT24 Plasma

PF24RT24 Plasma was distributed after incomplete donor eligibility screening.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

1 recall that day

Blood Bank of Hawaii Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

1 recall that day

Community Blood Center of Greater Kansas City Apheresis Red Blood Cells

Leukoreduced Apheresis Red Blood Cells products, collected from a donor whose health history screening was not adequately performed, were distributed.

Low risk, FDA, Ended, Hospital use, Donor screening problem

1 recall that day

American Red Cross Norfolk Main Site Apheresis Platelets and Red Blood Cells

American Red Cross Norfolk Main Site cells, for which Babesia testing was not performed, were distributed.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

1 recall that day

American National Red Cross Red Blood Cells, Leukocytes Reduced, Irradiated

American National Red Cross - Johnstown, PA products, for which Babesia testing was not performed, were distributed.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

1 recall that day

American National Red Cross Red Blood Cells

American National Red Cross Red Blood Cells, for which Babesia testing was not performed, were distributed.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem