Recall of Reagent Red Blood Cells

DATE RECALL INITIATED:

August 30, 2001

PRODUCT / LOT NUMBER

Panocell-10 32189 8/23/2001
Ficin Panocell-10 32189E 8/23/2001

MANUFACTURER:

Immucor
Norcross, GA 30071

REASON:

The phenotype of the cells in vial #4 is the same as vial #5. The results of any tests that were performed with the red cells from untreated vial #5 should be reviewed to determine if additional testing is necessary.

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.