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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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