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Biologic recalls tagged "Quality testing problem"

Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 82 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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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 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, FDA event number 99348

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

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 99172

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 99171

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 99163

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 99161

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, 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, FDA event number 99160

5 recalls that day

The Blood Center Platelets, Pathogen Reduced

Platelets, Pathogen Reduced 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 99158

LifeSouth Community Blood Centers Platelets, Pathogen Reduced

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

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99156

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 99150

3 recalls that day

The Blood Connection Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced 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

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 99149

Vitalant 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, FDA event number 99104

3 recalls that day

Medic Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were not tested for hemoglobin and residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99152

OneBlood Apheresis Red Blood Cells

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

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

West TN Regional Blood Center Platelets, Pathogen Reduced

Platelets, Pathogen Reduced were distributed without pH testing.

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

2 recalls that day

OneBlood 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

Mississippi Blood Services Apheresis and Red Blood Cells

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

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

3 recalls that day

Mississippi Blood Services Apheresis Platelets and Red Blood Cells

Apheresis red blood cells and platelets labeled as leukocytes reduced were not tested to verify the residual white blood cell count.

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

Medic 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, FDA event number 99086

ARUP Laboratories Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed without pH testing.

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

1 recall that day

Vitalant Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

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

1 recall that day

Medic Apheresis Platelets, Leukocytes Reduced, Irradiated

The platelets did not meet specifications.

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

1 recall that day

Department of Air Force Apheresis Platelets, Leukocytes Reduced

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

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

1 recall that day

Bloodworks Platelets Extended Dating

Platelets Extended Dating were distributed without a visual inspection.

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

1 recall that day

American National Red Cross Cryoprecipitated AHF

American National Red Cross Cryoprecipitated AHF, that failed to meet the minimum specifications for fibrinogen levels, were distributed.

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

1 recall that day

American National Red Cross Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were distributed without a visual inspection.

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

1 recall that day

New York Blood Center Apheresis Platelets, Leukocytes Reduced

The platelets were distributed with platelet yield that did not meet specifications.

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