BEUDAMED
    FDA Recall Terminated

    VITEK2 GP-ID, REF 21342 IVD

    Recall: Z-0074-2018 · Initiated October 11, 2017

    Recall

    Recall Number
    Z-0074-2018
    Event Number
    78288
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LQL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 11, 2017
    Terminated
    November 9, 2020
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    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, bioMrieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

    Action

    Consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on 10/11/2017. The direct consignees (subsidiaries and distributors) have until 11/11/2017 to notify their respective impacted users. The directions to the user are as follows: "Please implement the following actions at this time: We request you take the following action at this time: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " Please refrain from using the referenced test kits (VITEK 2 GP ID, Lots 2420240403, 2420303403, and 2420348103) in your laboratory. Destroy any of this product in your inventory, and contact your local bioMrieux representative for credit or replacement. " Please store this letter with your bioMrieux system documentation. "Complete the attached Acknowledgement Form and return it to your local bioMrieux representative."

    Distribution

    worldwide

    Quantity

    5672 cartons