BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2439-2019 · Initiated July 26, 2019

    Recall

    Recall Number
    Z-2439-2019
    Event Number
    83513
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JTC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 26, 2019
    Terminated
    December 6, 2019
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    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

    Action

    BD initiated a field correction via letter on July 26, 2019 and BD Technical Service has completed the correction (software upgrade) for all six (6) affected US customers. Letter identifies issue, health risk and customer action to take. BD is in the process of evaluating the log files of customers using the InoqulATM / InoqulA+TM software version 20.3 to determine if any users potentially experienced mismatch between a specimen and plate. BD will contact all customers using InoqulATM / InoqulA+TM software version 20.3 to provide the outcome of this evaluation. Contact: 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

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

    Quantity

    9 units