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Recalls and Significant Blood Safety Violations

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a malarial risk area).

2/6/08:
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a malarial risk area).

2/6/08:
Recalled 138 Red Blood Cells Products due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 657 Red Blood Cells Leukocytes Reduced Products due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 11 Red Blood Cells Leukocytes Reduced Irradiated Products due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 2 Red Blood Cells Leukocytes Reduced Washed Products due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 1 Red Blood Cells Pheresis Leukocytes Reduced Product due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 58 Platelets Leukocytes Reduced Products due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 204 Fresh Frozen Plasma Products due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 44 Platelets Leukocytes Reduced Products due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 53 Plasma Frozen Cryoprecipitate Reduced Products due to collection (sterility may have been compromised and failure to follow manufacturer's instructions).

2/6/08:
Recalled 172 Cryoprecipitated AHF Problems due to collection (sterility may have been compromised and failure

2/6/08:
to follow manufacturer's instructions). Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a malarial risk area).

2/6/08:
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a malarial risk area).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a malarial risk area).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a malarial risk area).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a malarial risk area).

The following excerpt is from page 1 of this 4-page FDA Inspection Report:

A. The Medical Director review of Donor Reaction and Injury Reports (DRIRs) is not always performed within a reasonable amount of time as outlined in Doc No 15.3.055, Version 1.l, Work Instruction: Performing Final Case and Donor Suitability Assessment.

1. [REDACTED TEXT] suffered an "arterial puncture" during blood collection on 11/12/09. The DRIR was initiated at the donation site on 11/12/09 and signed by the supervisor on 11/12/09. As of 9/20/10, when DRIRs were provided as part of this inspection, there has been no Medical Director Review. The donor returned to donate blood on 4/12/10 and 9/15/10.

Download the pdf file to read the complete inspection report.