BEUDAMED
    FDA Recall Terminated

    BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066

    Recall: Z-1313-2019 · Initiated April 3, 2019

    Recall

    Recall Number
    Z-1313-2019
    Event Number
    82616
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    PSZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 3, 2019
    Terminated
    May 4, 2020
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066

    Reason

    Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment

    Action

    BD notified customers by letter on 4/3/19 via FedX providing problem, health risk and action to take: BD is requesting that customers discard the affected instrument(s) for replacement. BD will replace your affected Veritor instrument(s) upon receipt of the Customer Response Form. BD Customer/Technical Support 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States.For customers outside the US, contact your local BD representative or distributor.

    Distribution

    Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan

    Quantity

    32 units