BEUDAMED
    FDA Recall Open, Classified

    Microdot Xtra blood glucose test strips

    Recall: Z-2357-2019 · Initiated July 26, 2018

    Recall

    Recall Number
    Z-2357-2019
    Event Number
    82867
    FEI Number
    3004176168
    Product Code
    NBW
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 26, 2018
    Address
    Cambridge Sensors Limited Units 9 & 10 Cardinal Park Huntingdon United Kingdom

    Description

    Microdot Xtra blood glucose test strips

    Reason

    The firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with new blades and did not correctly "notch" BG test strips intended for use in the US. The impacted strips did not fit into the inlet port of the BG meter, therefore resulting in a delay in BG testing and results.

    Action

    On July 26, 2018, the firm sent an email to it's US distributor that requested a sub-recall.

    Distribution

    Illinois

    Quantity

    17,784 (USA)