VIDAS 3 software v. 1.1.4 Cl II

Company: BioMerieux SA
Date of Enforcement Report 2/22/2017
Class lI:

PRODUCT

VIDAS 3 software v. 1.1.4
Recall Number Z-1200-2017

REASON
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.

RECALLING FIRM/MANUFACTURER
BioMerieux SA Chemin De L’Orme, France on 1/11/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1161 units

DISTRIBUTION
Nationwide

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