BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

    Recall: Z-0630-2022 · Reported February 16, 2022

    Enforcement

    Recall Number
    Z-0630-2022
    Event ID
    89358
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 16, 2022
    Initiation Date
    January 5, 2022
    Classification Date
    February 9, 2022
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

    Reason

    May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.

    Code Info

    All unexpired analyzers (Exp. Date 12/2021 - 8/2024) UDI: 00382902560661

    Distribution

    Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Fiji, Guatemala, Hong Kong, Honduras, Haiti, Indonesia, India, Jamaica, Cambodia, South Korea, Macao, Mexico, New Zealand, Panama, Peru, Philippines, Singapore, El Salvador, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Vietnam.

    Quantity

    126,952 Analyzers Updated:129, 848 Analyzers