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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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002