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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Vironostika HIV-1 Microelisa System-bioMerieux, Inc.

DATE RECALL INITIATED:

December 18, 2006

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Vironostika HIV-1 Microelisa System (Product # 259605, 259717)

Lot Number: 160354
Expiration: April 10, 2007

MANUFACTURER:

bioMerieux, Inc.
Durham, North Carolina

REASON:

bioMerieux, Inc is initiating a voluntary recall of the Vironostika HIV-1 Microelisa System for Lot# 160354. This recall is being conducted as a result of an internal quality investigation in which bioMerieux was able to confirm one customer complaint of no reactivity on a single coated plate from this lot. Under most conditions of use, a non-reactive plate would be detected by the kit's positive control. However, the potential for false negative results does exist if a customer combines strip wells from a reactive plate with strip wells from a non-reactive plate. This combination would result in a valid run if the kit controls were tested on the reactive strip. Customers are asked to stop using kit Lot# 160354 and return any unused kits.

 

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