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Recall of Anti-Jka Blood Grouping Reagent


DATE RECALL INITIATED:

October 11, 2002

LOT NUMBER / EXPIRATION DATE:

1F4424   7/11/2003

MANUFACTURER:

Immucor, Inc
Norcross, GA

REASON:

Post release analysis of Anti-Jka, lot 1F4424, demonstrated a reduction in potency. As a result, this reagent may not provide expected reactivity throughout the expiration dating of the product. Customers were advised that test results may be considered valid provided that testing was performed according to the package insert instruction, quality control testing gave acceptable results, and consideration was given to the "limitations" section of the package insert.

Consignees have been asked to contact the manufacturer to arrange for product return.


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.


Last Updated: 11/15/2002