Recall Z-0212-2009 ยท GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Inverness Medical BioStar Inc.
BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
| Date | Nov 3, 2008 (initiated Jul 2, 2008) |
| Status | Terminated |
| Reason | Diagnostic kits for flu were distributed with incorrect components. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 509 kits |
| Distribution | Nationwide Distribution --- including state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023556 | FLU OIA A/B TEST KIT Thermo Biostar, Inc., Mar 27, 2003 |