Recall Z-1506-2009 ยท GTZ Antisera, All Groups, Streptococcus Spp.
Binax, Inc. dba IMPD
Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
| Date | Jun 24, 2009 (initiated Apr 6, 2009) |
| Status | Terminated |
| Reason | Potential for false positive Strep A results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1,729 kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962060 | STREP A OIA MAX Biostar, Inc., Jul 23, 1997 |