BEUDAMED
    FDA Recall Terminated

    EasyRA Cuvette Segment 1, P/N 007000-001 (In Vitro Diagnostic ) EasyRA Cuvette Segments included in the following Kits: EasyRA Cuvettes, REF 10700-4 Startup Kit - Chemistry, REF 10990 Startup Kit - Chemistry & ISE, REF 10991

    Recall: Z-0078-2011 · Initiated March 29, 2010

    Recall

    Recall Number
    Z-0078-2011
    Event Number
    55150
    Firm
    Medica Corporation
    FEI Number
    1220972
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 29, 2010
    Posted
    October 18, 2010
    Terminated
    June 7, 2011
    Address
    5 Oak Park Dr, Bedford, MA, 01730

    Description

    EasyRA Cuvette Segment 1, P/N 007000-001 (In Vitro Diagnostic ) EasyRA Cuvette Segments included in the following Kits: EasyRA Cuvettes, REF 10700-4 Startup Kit - Chemistry, REF 10990 Startup Kit - Chemistry & ISE, REF 10991

    Reason

    Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results. The defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. The shortened path length was determined by measuring the cuvette dimensions with a Co-ordinate Measuri

    Action

    Medica issued an Urgent Product Recall letter dated March 29, 2010 to customers. Users were requested to cease using and discard the affected product, and complete and return a Response Form in order to obtain replacement product. Customers can contact Medica Technical Support at 877-777-5895.

    Distribution

    Worldwide Distribution: USA, and the countries of Bulgaria, Canada, India, Mexico, Panama, Phillipines, Russia, Turkey, New Zealand, South Africa, United Arab Emirates, and Venezuela.

    Quantity

    14,926