Device recall
Z-0256-2008: BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG…
FDA device recall · Class III · Bio-Rad Labroatories Inc.
Key facts
| Recall number (Z-number) | Z-0256-2008 |
|---|---|
| Recall event | 45332 |
| Product | BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD |
| Product code | LIP |
| Recalling firm | Bio-Rad Labroatories Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 16, 2008 |
| 510(k) numbers | K063866 |
| FEI number | 2915274 |
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