BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
FDA device recall Z-0212-2009 · posted 2008-11-03 · Terminated
Recall details
- Recalling firm
- Inverness Medical BioStar Inc.
- Reason for recall
- Diagnostic kits for flu were distributed with incorrect components.
- Action taken
- Consignees were notified by a Important Customer Notification letter on 7/2/2008 and told to re-examine patient records that indicated a negative result and to destroy any remaining recalled product. The accompanying record should be filled out and faxed to Technical Service. If consignees further distributed any kits, they were to forward the notification to these accounts to assure that patient results were reviewed, and destruction of remaining kits could be verified. For assistance, customers can call 800-637-3717.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- GNX
- Quantity affected
- 509 kits
- Distribution
- Nationwide Distribution --- including state of IL.
- Date initiated
- 2008-07-02
- Date posted
- 2008-11-03
- Date terminated
- 2008-11-04
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLU OIA A/B TEST KIT (K023556) | Thermo Biostar, Inc. | 2003-03-27 |