Biomerieux Inc recalls BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

Recall date

October 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0928-2020

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

US

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation