BEUDAMED
    FDA Enforcement Class II Terminated

    UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

    Recall: Z-0855-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0855-2015
    Event ID
    69856
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Unistrip Technologies LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2014
    Initiation Date
    November 20, 2014
    Classification Date
    December 23, 2014
    Termination Date
    May 20, 2015
    Address
    301 Mccullough Dr, Suite 400, Charlotte, NC, 28262-3310, United States

    Description

    UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

    Reason

    Failure to submit a 510(k) for device labeling changes.

    Code Info

    U14030713, 814031313, U140312323, and U14031413.

    Distribution

    US Distribution to the states of FL and OH.

    Quantity

    7175 units