FDA Device

Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.

Hazard

Potential for false positive Strep A results.

What You Should Do

Remedy

Inverness Medical notified Customers by letter sent via Fedex April 6, 2009 . The letter included a request for a response from the customer. The product is discontinued.

Products

Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
Brand
Binax, Inc. dba IMPD
UPC
All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09;  196278, 196279, 196280, and 196281, expire 06/30/09.

Units Affected

1,729 kits