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Recalls and Significant Blood Safety Violations

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09:
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to component preparation (product manufactured from an overweight unit of Whole Blood).

10/30/09:
Recalled 4 Red Blood Cells (Apheresis) Leukocytes Reduced Products due to component preparation (failure to per- form required product quality control testing).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09:
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09:
Recalled 1 Red Blood Cells Reduced Product due to component preparation (product manufactured from an overweight unit of Whole Blood).

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 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 Platelets Leukocytes Product due to donor eligibility (failure to defer donor for travel in a malarial risk area).

The following excerpt is from page 2 of this 2-page FDA Inspection Report:

Case id #(b)(4) was for a donor reaction involving a 4 1/2" bruise reported by donor call back on 11/20/09. This record has not had Medical Director Review or Final Quality Review as of 4/22/10.

Case id #(b)(4) for a donor reaction involving dizzy/lightheadedness and a bruise/swelling a little larger than a golfball reported by donor call back on 11/5/09. The donor subsequently called in and stated (b) (6) experienced additional lightheadedness and was transported by EMS to (b) (6) on 11/5/09. This record has not had Medical Director Review or Final Quality Review as of 4/22/1O.

Case id #(b)(4) was for a donor reaction involving large hematoma on 11/27/09. This record had Medical Director Review and Final Quality Review on 2/19/10.

Case id #(b)(4) was for a donor reaction involving dizzy/lightheadedness and seizure/convulsion on 11/25/09. This record had Medical Director Review on 1/26/10 and Final Quality Review as of 2/19/10.

Download the pdf file to read the complete inspection report.