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.
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 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, and
- 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.
See all 3 products in this recall →Related recalls
Same manufacturer · bioMerieux, Inc.
See all →- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25