Events

Recall of Device Recall VIDAS 3 software v. 1.1.4

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioMerieux SA.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76281
  • Event Risk Class
    Class 2
  • Event Number
    Z-1200-2017
  • Event Initiated Date
    2017-01-11
  • Event Date Posted
    2017-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152632
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Enzyme linked immunoabsorbent assay, cytomegalovirus - Product Code LFZ
  • 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.
  • Action
    Consignees were notified via letter on January 11th, 2017.

Device

Device Recall VIDAS 3 software v. 1.1.4

Manufacturer

BioMerieux SA
  • Manufacturer Address
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA