Recall
Uni-Gold Recombigen HIV
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.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.