Recall Z-1506-2009
Binax, Inc. dba IMPD · initiated April 6, 2009
Product
Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
Codes / lots: All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09; 196278, 196279, 196280, and 196281, expire 06/30/09.
Reason for recall
Potential for false positive Strep A results.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1506-2009
- Initiated
- April 6, 2009
- Posted by FDA
- June 24, 2009
- Terminated
- January 6, 2010
- Product code
- GTZ – Antisera, All Groups, Streptococcus Spp.
- Quantity
- 1,729 kits
- Distribution
- Nationwide.
- Recalling firm
- Binax, Inc. dba IMPD, Scarborough, ME