Binax, Inc. dba IMPD Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
Brand
Binax, Inc. dba IMPD
Lot Codes / Batch Numbers
All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09, 196278, 196279, 196280, and 196281, expire 06/30/09.
Products Sold
All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09; 196278, 196279, 196280, and 196281, expire 06/30/09.
Binax, Inc. dba IMPD is recalling Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnos due to Potential for false positive Strep A results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for false positive Strep A results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026