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

1127695     1/3/2002

MANUFACTURER:

Gamma Biologicals,Inc.
Houston, TX

REASON:

The recalled products are used by blood bank laboratories to identify unexpected antibodies. The recalling firm received and confirmed one report that the phenotype of the red cells contained in vial 7 of the untreated panel is the same as the cells in vial 3. An investigation of the in-house samples did not find another example of this occurrence. The recalling firm has asked customers to 1) discontinue use of these products immediately, 2) discard any remaining vials of lot 1127695. Customers are advised to review the results of any tests that were performed with the red cells from untreated vial 7 to determine the necessity of additional testing. The presence or absence of an antibody should not be solely based on the results of a test with these cells.

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.