FDA Device recall Z-0229-2019
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated…
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated… by Biomerieux, citing the BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0229-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-27 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
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 growth from blood and other normally sterile body fluids.
Reason
The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards are not returned to the designated locations, an anomaly may occur.
Identifiers
| code_info | Reference Number 411661, UDI 03573026369774, all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.