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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
(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