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Biologic recalls tagged "Labeling error"

Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 24 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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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

1 recall that day

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

2 recalls that day

American National Red Cross Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but were collected from a donor who tested antigen positive.

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

American National Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but were collected from a donor who tested antigen positive.

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

3 recalls that day

Blood Assurance Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed without a tag indicating they contained antibodies.

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

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

San Antonio Eye Bank Cornea

A mislabeled cornea was distributed.

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

American Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but were collected from a donor who tested positive.

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

1 recall that day

The Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were incorrectly labeled as irradiated and distributed.

Moderate risk, FDA, Ended, Hospital use, Labeling error, FDA event number 98875

1 recall that day

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

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

1 recall 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, FDA event number 99202

1 recall that day

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

1 recall 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

1 recall that day

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

1 recall that day

LifeSouth Community Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced

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

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

1 recall 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

1 recall that day

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

3 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, FDA event number 99092

OneBlood Apheresis Red Blood Cells, Leukocytes Reduced

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

Moderate risk, FDA, Ended, Hospital use, Labeling error, FDA event number 99091

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

2 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