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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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1 recall that day

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced were not tested for pH or platelet count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 100028

1 recall that day

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for residual white blood cells or red blood cells after an RBC spillover.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 100025

1 recall that day

Greer Laboratories Sterile Diluent for Allergenic Extract

Sterile Diluent for Allergenic Extract, Normal Saline has a lower than expected phenol level.

Low risk, FDA, Clinic use, Quality testing problem

2 recalls that day

American Red Cross Blood Svcs Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced may have exceeded the acceptable collection volume.

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

We Are Blood Pooled Platelets, Leukocytes Reduced, Irradiated

Pooled Platelets, Leukocytes Reduced, Irradiated were not tested for pH.

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

1 recall that day

ARUP Laboratories Apheresis Platelets, PAS, Leukocytes Reduced

The platelets were labeled as leukocytes reduced but were not tested to verify residual white blood cell count, and pH testing was not performed.

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

2 recalls that day

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced were not tested for pH or platelet yield.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 100018

South Texas Blood & Tissue Center 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

1 recall that day

Versiti Illinois 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

7 recalls that day

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 99170

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 99169

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99168

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 99167

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 99166

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 99165

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 99164

4 recalls that day

New York Blood Center Apheresis Platelets, Leukocytes Reduced

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

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

West TN Regional Blood Center Apheresis Platelets

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

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

LifeStream Blood Bank Red Blood Cells, Leukocytes Reduced

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

OneBlood Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated

Apheresis Red Blood Cells, Leukocytes Reduced, 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

2 recalls that day

Penn State Health Holy Spirit Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed with incomplete testing.

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

ImpactLife Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.

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

2 recalls that day

American National Red Cross Apheresis Platelets

Apheresis Platelets were distributed without being tested for pH or platelet yield.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99624

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

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 98800

1 recall that day

LifeShare Blood Center Apheresis Platelets, Leukocytes Reduced

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

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

1 recall that day

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

The platelets did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99488

2 recalls that day

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

The product did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99487

Medic Apheresis Platelets and Platelets Extended Dating

Apheresis Platelets, Leukocytes Reduced, Irradiated, with a platelet count higher than was acceptable, were distributed.

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

1 recall that day

Vitalant Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.

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

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

2 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

1 recall that day

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, FDA event number 99486

1 recall that day

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

1 recall that day

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

1 recall that day

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

1 recall 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

1 recall 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

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

3 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 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

3 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 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