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FDA biologic recalls

Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 222 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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2 recalls that day

New York Blood Center Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated had a platelet count higher than acceptable.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

New York Blood Center Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated may have been manufactured with an incorrect ratio of blood to anticoagulant.

Low risk, FDA, Ended, Hospital use, Quality testing problem

3 recalls that day

American National Red Cross Blood Services Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for pH and were distributed.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

Vitalant Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

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

Red Blood Cells, Leukocytes Reduced, Irradiated may have been prepared incorrectly.

Moderate risk, FDA, Ended, Hospital use

1 recall that day

Baxter Anticoagulant Sodium Citrate Solution

Anticoagulant Sodium Citrate Solution may contain fiberglass particles that can cause adverse health consequences.

High risk, FDA, Hospital use, Foreign object

1 recall that day

Suncoast Communities Blood Bank Red Blood Cells and Whole Blood

Suncoast Communities Blood Bank Red Blood Cells and Whole Blood, collected from donors for whom donor eligibility screening was incomplete, were distributed.

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

2 recalls that day

OneBlood Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a therapeutic donor incorrectly registered as allogeneic.

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

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

The product did not meet specifications for platelet yield.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

3 recalls that day

New York Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor previously deferred for hepatitis C virus antibody testing.

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

Hoxworth 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 99471

Walter L. Shepeard Community 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

3 recalls that day

LifeShare Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were distributed after incomplete donor eligibility screening.

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

LifeShare 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 99418

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were prepared from whole blood that exceeded the acceptable collection volume.

Low risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99427

2 recalls that day

Hoxworth 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 99417

LifeShare 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 99416

4 recalls that day

Suncoast Communities Blood Bank Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were collected from a donor who had recently traveled to a malaria endemic area.

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

Blood Assurance Pooled Cryoprecipitated AHF and Red Blood Cells

Red Blood Cells and Pooled Cryoprecipitated AHF were collected from a donor at increased risk for Creutzfeldt-Jakob Disease.

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

LifeSouth Community Blood Centers Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated were distributed without required testing for hematocrit and red cell volume.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

The Blood Connection Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were exposed to unacceptable storage temperatures.

Low risk, FDA, Ended, Hospital use, Processing 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 was a resident of a malaria endemic area.

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

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were distributed without platelet yield testing.

Low risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99396

2 recalls that day

American Natl. Red Cross Apheresis Platelets, PAS, Leukocytes Reduced

Apheresis Platelets, PAS, Leukocytes Reduced, were collected on an instrument undergoing equipment qualification and without quality control testing.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

American National Red Cross Apheresis Platelets

Apheresis platelets labeled as leukocytes reduced failed a monthly residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Labeling error, FDA event number 99394

2 recalls that day

American Red Cross Blood Services Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

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

The Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count, were distributed.

Moderate risk, FDA, Ended, Hospital use, Labeling error

Octapharma Octagam Immune Globulin (Human)

There is the potential for damaged units being on the US market.

Moderate risk, FDA, Hospital use

1 recall that day

AXP Processing Bag Set

AXP Processing Bag Set may release particulates into the sterile fluid path.

Moderate risk, FDA, Ended, Foreign object

3 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

Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced lack proper documentation of antigen typing.

Moderate risk, FDA, Ended, Hospital use

3 recalls that day

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The platelets did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99187

Versiti Blood Health Apheresis Platelets, Leukocytes Reduced, Irradiated

The pH of the product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99185

4 recalls that day

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99184

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The platelet yield did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99183

LifeSouth Community Blood Centers Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed without being labeled as containing red blood cell antibodies.

Low risk, FDA, Ended, Hospital use, Labeling error

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99181

4 recalls that day

Mississippi Blood Services Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced lack documentation of acceptable storage temperature.

Moderate risk, FDA, Ended, Hospital use

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99180

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99179

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99178

4 recalls that day

LifeServe Blood Center Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were manufactured with an unknown quantity of additive solution.

Low risk, FDA, Ended, Hospital use, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99177

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99175

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99174

4 recalls that day

Vitalant Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The product did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99173