BEUDAMED
    FDA Recall Terminated

    Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA

    Recall: Z-1013-2010 · Initiated June 15, 2009

    Recall

    Recall Number
    Z-1013-2010
    Event Number
    52719
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 15, 2009
    Posted
    March 5, 2010
    Terminated
    February 2, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA

    Reason

    Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.

    Action

    Recall initiated June 15, 2009, with notification initially conducted by phone with Fax Notification follow up domestically. Each subsidiary will be given an urgent notice, subsidiary response form, customer notification, customer acknowledgement form. Each subsidiary is to contact customers and translate notification and response form as needed. Contact the recalling firm for additional information.

    Distribution

    Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, and the United Kingdom

    Quantity

    613 units