Device recall
Z-0229-2019: BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The…
FDA device recall · Class II · bioMerieux, Inc.
Key facts
| Recall number (Z-number) | Z-0229-2019 |
|---|---|
| Recall event | 80759 |
| Product | BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism… |
| Product code | MDB |
| Recalling firm | bioMerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2020 |
| FEI number | 3002769706 |
At a glance
- None 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