BEUDAMED
    FDA Recall Terminated

    VITEK 2 Systems Software Version 9.01 Update Kit.

    Recall: Z-0639-2019 · Initiated November 13, 2018

    Recall

    Recall Number
    Z-0639-2019
    Event Number
    81589
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 13, 2018
    Terminated
    July 7, 2021
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VITEK 2 Systems Software Version 9.01 Update Kit.

    Reason

    The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP" feature.

    Action

    bioMerieux notified customers of the recall on about 11/13/2018 via "URGENT PRODUCT CORRECTION NOTICE." Instructions included taking the following actions: 1) Confirm the letter has been distributed to, and reviewed by, all appropriate personnel; 2) If appropriate in accordance with consignee's laboratory's Standard Operating Procedures, perform retrospective review of any patient results potentially impacted in relation to the described VITEK FLEXPREP anomaly; 3) Store this letter with the bioMrieux, Inc. VITEK 2 instrument documentation; 4) Complete and return the Acknowledgement Form in Attachment A to confirm receipt of the notice and return it to your local bioMrieux, Inc. representative. Regardless of each consignee's current use of the VITEK FLEXPREP" feature, your local Field Service Engineer has implemented the software solution on your VITEK 2 System. If you require additional assistance or have any questions, please contact your local bioMrieux, Inc. Clinical Customer Service representative at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at [email protected]. The anticipated turnaround time for email inquiries is 24-48 hours during normal business hours (7AM 7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.

    Distribution

    Nationwide distribution to CO, IL, MO, TX.

    Quantity

    five (5) VITEK¿ 2 Systems Software version 9.01