Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
FDA device recall Z-1506-2009 · posted 2009-06-24 · Terminated
Recall details
- Recalling firm
- Binax, Inc. dba IMPD
- Reason for recall
- Potential for false positive Strep A results.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GTZ
- Quantity affected
- 1,729 kits
- Distribution
- Nationwide.
- Date initiated
- 2009-04-06
- Date posted
- 2009-06-24
- Date terminated
- 2010-01-06
- Location
- Scarborough, ME
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STREP A OIA MAX (K962060) | Biostar, Inc. | 1997-07-23 |