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.