BEUDAMED
    FDA Recall Terminated

    HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    Recall: Z-2190-2013 · Initiated July 15, 2013

    Recall

    Recall Number
    Z-2190-2013
    Event Number
    65854
    Firm
    HemoCue AB Kuvettgaten 1 Angelholm Sweden
    FEI Number
    3003044483
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 15, 2013
    Posted
    September 11, 2013
    Terminated
    September 2, 2014

    Description

    HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    Reason

    During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

    Action

    HemoCue sent an Urgent Field Safety Notice dated July 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine any affected product and Return the Field Safety Notice Verification Form to e-mail: [email protected] or fax 562-668-5794 Customers would be contacted to coordinate return and replacement of the affected microcuvettes. Customers with questions were instructed to call 800-426-7256. For questions regarding this recall call 440-925-3485.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIAN FEDERATION, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, VIET NAM & YEMEN. .

    Quantity

    22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US