BEUDAMED
    FDA Enforcement Class II Terminated

    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.

    Recall: Z-0909-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0909-2014
    Event ID
    67152
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nipro Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    October 2, 2013
    Classification Date
    February 3, 2014
    Termination Date
    January 28, 2016
    Address
    2400 NW 55th Ct, Ft Lauderdale, FL, 33309-2672, United States

    Description

    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.

    Reason

    Manufactured with an incorrect factory set unit of measure.

    Code Info

    Finished Good: KK0468; Lot Numbers: KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, KP0925TI.

    Distribution

    Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.

    Quantity

    501