BEUDAMED
    FDA Enforcement Class II 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 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1313-2019
    Event ID
    82616
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2019
    Initiation Date
    April 3, 2019
    Classification Date
    May 10, 2019
    Termination Date
    May 4, 2020
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212, United States

    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

    Code Info

    Serial Numbers: Serial Number 1807138J1E050 1710067J160C0 1703027J07FD0 1810268J2D370 1710217J18470 1703027J084C0 1703307J0C630 1710067J16190 1709187J12360 1710267J19D40 1710067J16230 1710067J161D0 1710067J161F0 1710067J16260 1807138J1E0B0 1609076J04270 1802138J07B40 1803298J11070 1802078J05D80 1704067J0DA00 1612166J070C0 1710257J18F50 1802028J044C0 1703167J0B0B0 1612026J07010 1710067J16110 1802058J05210 1811128J2FF50 1710067J16200 1710067J16270 1710237J185C0 1702147J04360

    Distribution

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

    Quantity

    32 units