BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

    Recall: Z-0928-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0928-2020
    Event ID
    84464
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 12, 2020
    Initiation Date
    October 22, 2019
    Classification Date
    January 31, 2020
    Termination Date
    August 6, 2024
    Address
    595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States

    Description

    BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

    Reason

    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.

    Code Info

    software versions 1.2 and higher

    Distribution

    US

    Quantity

    738 units