Recall of Reagent Red Blood Cells,
Gamma Panel One and Gamma Ficin Panel One

DATE RECALL INITIATED:

December 21, 2001

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Gamma Panel One
Gamma Ficin Panel One

1211710     1/16/2002

MANUFACTURER:

Gamma Biologicals,Inc.
Houston, TX

REASON:

The recalled products are used by blood bank laboratories to identify unexpected antibodies. The antigen profile sheet accompanying each product contains an error. The red cells of Cell #6 of each panel, donor rrV-19581, are listed as VS-. This is not correct. The red cells of Cell #6 have not been tested for the VS antigen. Antigens for which testing has not been performed should be designated with a back-slash (/). Customers are advised to replace the antigen profile sheets received with the panel shipment with the antigen profile sheet that accompanies the Field Correction letter. The correct antigen profile sheet has a “B” in the upper left-hand corner.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.