Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0229-2019·Announced 2018-10-31

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.

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 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…
Manufacturer: bioMerieux, Inc.
Category: Medical Device — Laboratory Equipment
Hazard: software-defect
calibration-error
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

Distributed nationwide across the United States.

The notice also names 26 states specifically:

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 →

Same manufacturer · bioMerieux, Inc.

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