BioMerieux SA recalls VIDAS 3 software v. 1.1.4

Recall date

January 11, 2017

Source

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

Recall number

Z-1200-2017

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

U.S.

Why it was recalled

During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.

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

What was recalled

VIDAS 3 software v. 1.1.4