BEUDAMED
    FDA Enforcement Class II Terminated

    VITEK2 GP-ID, REF 21342 IVD

    Recall: Z-0074-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0074-2018
    Event ID
    78288
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2017
    Initiation Date
    October 11, 2017
    Classification Date
    November 8, 2017
    Termination Date
    November 9, 2020
    Address
    595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States

    Description

    VITEK2 GP-ID, REF 21342 IVD

    Reason

    Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

    Code Info

    UDI 03573026131920, Lot Number 2420348103

    Distribution

    worldwide

    Quantity

    5672 cartons