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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Uni-Gold Recombigen HIV-Trinity Biotech USA

DATE RECALL INITIATED:

February 12, 2008

PRODUCT / LOT NUMBER/EXPIRATION DATE:

Uni-Gold Recombigen HIV

Product Number: 1206506
Lot Number: R288013
Expiration Date: October 2, 2008

MANUFACTURER:

Trinity Biotech USA
Jamestown, New York

REASON:

There is a potential of false positive results on negative patients samples, while negative results remain true negatives. Customers are instructed to discontinue use of this lot and a re-evaluation of positive patient results is recommended if they have not been confirmed with a highly specific second tier test such as Western Blot.

 

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