Device recall
Z-3129-2011: VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for…
FDA device recall · Class II · bioMerieux, Inc.
Key facts
| Recall number (Z-number) | Z-3129-2011 |
|---|---|
| Recall event | 59601 |
| Product | VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique (Enzyme Linked Fluorescent Assay. |
| Product code | LJC |
| Recalling firm | bioMerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2012 |
| 510(k) numbers | K905787 |
| FEI number | 3002769706 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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