Device recall
Z-2232-2014: VIDAS D-Dimer Exclusion II, an automated quantitative test for use on…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-2232-2014 |
|---|---|
| Recall event | 68747 |
| Product | VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest… |
| Product code | DAP |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2014 |
| 510(k) numbers | K112818 |
| FEI number | 1000611339 |
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