BEUDAMED
    FDA Enforcement Class II Terminated

    BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

    Recall: Z-2439-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2439-2019
    Event ID
    83513
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    July 26, 2019
    Classification Date
    August 30, 2019
    Termination Date
    December 6, 2019
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

    Reason

    An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

    Code Info

    Catalog Number: 447213 Serial Number/UDI: INO-000290 00382904472139 INO-000263 00382904472139 INO-000264 00382904472139 20130276 00382904472139 INO-000282 00382904472139 INO-000284 00382904472139 INO-000272 00382904472139 INO-000274 00382904472139

    Distribution

    Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands

    Quantity

    9 units