BEUDAMED
    FDA Recall Terminated

    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. 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-0910-2014 · Initiated October 2, 2013

    Recall

    Recall Number
    Z-0910-2014
    Event Number
    67152
    Firm
    Nipro Diagnostics, Inc.
    FEI Number
    1000113657
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    October 2, 2013
    Posted
    February 3, 2014
    Terminated
    January 28, 2016
    Address
    2400 NW 55th Ct, Ft Lauderdale, FL, 33309-2672

    Description

    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. 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.

    Action

    Nipro Diagnostics sent an Urgent Medical Device Voluntary Recall letter dated December 31, 2013 to all affected customers. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the serial numbers listed on the back of the products. 2) If they have any of the affected products, return the product by contacting Stericycle at 1-866-236-4518. 3) Complete and return the enclosed response form via fax at 1-888-358-7294. Customers with questions were instructed to call Stericycle at 1-866-236-4518. For questions regarding this recall call 954-677-9201.

    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

    105