Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BACT/ALERT VIRTUO system Recalled by bioMerieux, Inc. Due to The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows...

Date: June 27, 2018
Company: bioMerieux, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact bioMerieux, Inc. directly.

Affected Products

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 anaerobic microorganism growth from blood and other normally sterile body fluids.

Quantity: 151 units

Why Was This Recalled?

The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards are not returned to the designated locations, an anomaly may occur.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About bioMerieux, Inc.

bioMerieux, Inc. has 53 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report