Class II — Potential Health Hazard

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

BIOMERIEUX VIDAS 3 Recalled by Biomerieux Inc Due to Following Customers complaints, investigations have been initiated on...

Date: October 22, 2019
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

BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

Quantity: 738 units

Why Was This Recalled?

Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.

Where Was This Sold?

US

About Biomerieux Inc

Biomerieux Inc has 368 total recalls tracked by RecallDetector.

Related Recalls

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