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Recalls and Significant Blood Safety Violations

10/30/09:
Collection staff relabeled whole blood units without determining whether test results were properly associated with the correct unit and whether the units could be traced to the correct donor. Associates components of these blood units were improperly distributed.

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to follow up on medications taken by donor).

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

Failure to perfonn a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.

Specifically, there was no problem logged, investigation or corrective action entered into the automated problem management system (APMS) as required for Case ID [REDACTED TEXT]. Donor [REDACTED TEXT] had an injury involving a contaminated needle stick to her during the venipuncture procedure. The phlebotomist reported while removing the needle cap she "poked" her finger (no blood or visible injury noted) and proceeded to stick the donor with the unsterile needle. Afterwards she "noticed a drop of blood" on her glove and informed the donor of the incident. The medical director was not notified of the donor injury until 07/20/10 by the Donor and Client Support Center (DCSC). The donor was temporarily deferred for 12 months on 07/23/10.

Download the pdf file to read the complete inspection report.