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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Market Withdrawal of LAL Reagent - Associate of Cape Cod

DATE WITHDRAWAL INITIATED:

March 9, 2007

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Pyrotell Multitest

Catalog Number: G2006 Lot Number: 206-09-395 Expiration Date: 07 Sep 2011
Catalog Number: G5006 Lot Number: 506-09-396 Expiration Date; 11 Sep 2011

MANUFACTURER:

Associate of Cape Cod
East Falmouth, MA

REASON:

This product was released with a labeled sensitivity of 0.06 EU/mL. Some samples recently tested from this lot have shown a change in sensitivity. The specifications for this product permit a twofold greater or lesser sensitivity than labeled claim. Recent results indicate that the lot is intermittently giving an endpoint of 0.25 EU/mL, a four-fold difference from label claim.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448