bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue
bioMerieux is recalling 151 BACT/ALERT VIRTUO systems with R2.0 firmware because a software feature may allow calibration standards to be left in incorrect positions, 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 describes a potential anomaly without reporting any hospitalizations, significant injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
bioMerieux, Inc. is recalling 151 units of the BACT/ALERT VIRTUO system, B Unit, equipped with Version R2.0 Firmware. The product is an automated microbial detection system used to incubate, agitate, and monitor for the growth of aerobic, facultative, and anaerobic microorganisms from blood and other normally sterile body fluids.
The recall is due to a firmware feature that allows Field System Engineers to relocate four resident calibration standards to service specific cells (P24 - P27). If these standards are not returned to their designated locations after servicing, an anomaly may occur in the system. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. The recall includes Reference Number 411661, UDI 03573026369774, and all serial numbers. Healthcare facilities and users should contact bioMerieux for instructions on how to address the firmware issue.
The recalled product
- 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 anaer
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 151
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 411661
- UDI 03573026369774
- 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