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DATE RECALL INITIATED: September 15, 2002 LOT NUMBER / EXPIRATION DATE: 502-03-244     3/8/2007 MANUFACTURER: Associates of Cape Cod 704 Main Street Falmouth, MA 02540 REASON: Test results have indicated that this lot was released with a labeled sensitivity of 0.25 EU/ml. The specifications for this product permit gel clot formation, in the presence of bacterial endotoxin, at up to two-fold greater or lesser sensitivity than label claim. Recent testing has indicated that this lot has become more sensitive and forms gel clots at 0.06 EU/ml, a four-fold greater sensitivity than label claim. Thus, it is possible that endotoxin testing with this lot, using the labeled sensitivity, could result in greater test stringency than expected. 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.

Updated October 8, 2002

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