bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue
bioMerieux is recalling 516 BACT/ALERT VIRTUO systems with R2.0 firmware because a service feature may leave calibration standards in incorrect locations, potentially causing anomalies.
What this means for you
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a potential system anomaly resulting from a specific service procedure, which aligns with the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
bioMerieux, Inc. is recalling 516 units of the BACT/ALERT VIRTUO system, A Unit, equipped with Version R2.0 Firmware. The recall is limited to units with Reference Number 411660 and UDI 03573026369767, covering all serial numbers. The affected devices are automated microbial detection systems used to incubate, agitate, and monitor for the growth of aerobic, facultative, and anaerobic microorganisms in blood and other normally sterile body fluids.
The recall is due to a firmware issue in Version R2.0. This version allows Field System Engineers to relocate four resident calibration standards to service associated cells P24 through P27. If the calibration standards are not returned to their designated locations after servicing, an anomaly may occur in the system.
The affected units were distributed worldwide, including nationwide distribution in the United States across 26 states and internationally to numerous countries including Austria, Australia, Belgium, Brazil, Canada, and others. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- BACT/ALERT VIRTUO system, A 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 anaer
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 516
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 411660
- UDI 03573026369767
- 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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