bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue
bioMerieux is recalling 8 BACT/ALERT VIRTUO systems because firmware version R2.0 allows calibration standards to be moved, potentially causing anomalies if not returned to designated locations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential operational anomaly rather than a direct risk of serious injury or death, and no illnesses or injuries are reported. This aligns with a moderate severity rating for a precautionary technical recall.
Plain-English summary
bioMerieux, Inc. is recalling 8 units of the BACT/ALERT VIRTUO system, A Unit China, equipped with Version R2.0 Firmware. The recall is due to a software issue where the firmware allows Field System Engineers to relocate four resident calibration standards to service associated cells P24 through P27. If these calibration standards are not returned to their designated locations after servicing, an anomaly may occur in the system's operation.
The affected units were distributed worldwide, including nationwide distribution in the United States across 27 states and internationally to numerous countries including Canada, the United Kingdom, Germany, and Japan. The specific units are identified by Reference Number 419947 and UDI 03573026509538, covering all serial numbers for this specific configuration.
Healthcare facilities and users of the BACT/ALERT VIRTUO system should contact bioMerieux, Inc. for instructions on how to resolve the firmware issue and ensure calibration standards are correctly positioned. The system is an automated microbial test system used for detecting microorganism growth from blood and other sterile body fluids.
The recalled product
- Product
- BACT/ALERT VIRTUO system, A Unit China, 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…
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Reference Number 419947
- UDI 03573026509538
- all serial numbers
Distribution
Part of a larger recall action
This product is one of 3 recalled by bioMerieux, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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