Device recall
Z-0212-2009: BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar…
FDA device recall · Class II · Inverness Medical BioStar Inc.
Key facts
| Recall number (Z-number) | Z-0212-2009 |
|---|---|
| Recall event | 49385 |
| Product | BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027 |
| Product code | GNX |
| Recalling firm | Inverness Medical BioStar Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2008 |
| 510(k) numbers | K023556 |
| FEI number | 1720655 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database