Device recall
Z-2428-2018: BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*)…
FDA device recall · Class II · bioMerieux, Inc.
Key facts
| Recall number (Z-number) | Z-2428-2018 |
|---|---|
| Recall event | 79993 |
| Product | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the… |
| Product code | JJE |
| Recalling firm | bioMerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2022 |
| 510(k) numbers | K923579 |
| FEI number | 3002769706 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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