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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
(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