Device recall
Z-1156-2008: BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured…
FDA device recall · Class II · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-1156-2008 |
|---|---|
| Recall event | 45875 |
| Product | BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidium IgG antibodies in human serum. |
| Product code | LIP |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2011 |
| 510(k) numbers | K063866 |
| FEI number | 3008272466 |
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