Device recall
Z-1159-2008: BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150…
FDA device recall · Class II · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-1159-2008 |
|---|---|
| Recall event | 45875 |
| Product | BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases. |
| Product code | LKJ |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2011 |
| 510(k) numbers | K043341 |
| 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