Search

Recalls and Significant Blood Safety Violations

10/30/09:
Whole blood unit was potentially contaminated by exposure to air during collection and the associated products were shipped before the collections staff reported the error.

10/30/09:
Recalled 10 Platelets Pheresis Leukocytes Reduced Products due to storage/shipping (blood components may have been shipped at unacceptable temperatures).

10/30/09:
Recalled 3 Platelets Pheresis Leukocytes Reduced Irradiated Products due to storage/shipping (blood components may have been shipped at unacceptable temperatures).

2/6/08:
Recalled 1 Red Blood Cells Product due to testing (failure to follow manufacturer's instructions for syphilis).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to testing (failure to follow manufacturer's instructions for syphilis).

2/6/08:
Recalled 3 Red Blood Cells Pheresis Leukocytes Reduced Products due to testing (failure to follow manufacturer's instructions for syphilis).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduces 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 (Blood Donation Record gender related questions were unanswered).

2/6/08:
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (Blood Donation Record gender related questions were unanswered).

2/6/08:
Recalled 2 Platelet Pheresis Leukocytes Reduced Irradiated Products due to storage/shipping (products shipped under unacceptable temperatures).

2/6/08:
Recalled 2 Red Blood Cells Leukocytes Reduced Products due to collection (sterility may have been compromised).

2/6/08:
Recalled 1 Frozen Plasma Product due to collection (sterility may have been compromised).

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

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

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

The following excerpt is from page 1 of this 3-page FDA Inspection Report:

Written standard operating procedures including all steps to be followed in the collection, processing, and storage of blood and blood components for homologous transfusion are not always followed.

Specifically,

1. Failure to follow Job Aid 15.4ja037, Short Loss of Consciousness. This Job Aid requires staff to handle all reactions where the donor has seizures or convulsions or loss of bladder or bowel control as a long loss of consciousness to ensure follow-up (15.4.ja-038).

a. A donor donated on 2/9/2009 (case # C200902101516o2w) and had a loss of consciousness for less than a minute 3 times during donation. The donor also lost bladder control. Staff documented the reaction as a Major Other (XO) and a Prolonged Recovery (XP). The donor was not treated as a Long Loss of Consciousness (XF).

Download the pdf file to read the complete inspection report.