BEUDAMED
    FDA Enforcement Class II Ongoing

    Microdot Xtra blood glucose test strips

    Recall: Z-2357-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2357-2019
    Event ID
    82867
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cambridge Sensors Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 28, 2019
    Initiation Date
    July 26, 2018
    Classification Date
    August 22, 2019
    Address
    Units 9 & 10, Cardinal Park, Huntingdon, N/A, N/A, 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.

    Code Info

    LOT NUMBERS 7091101, 7091201, 7091801, 7091902, 7100402, 7100403, 7101002, 7101602, 7101702, 7102403, 7103002, 7110602, 7110703, and 7112702.

    Distribution

    Illinois

    Quantity

    17,784 (USA)