BEUDAMED
    FDA Recall Terminated

    D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.

    Recall: Z-0965-2014 · Initiated November 22, 2013

    Recall

    Recall Number
    Z-0965-2014
    Event Number
    66947
    Firm
    Bio-Rad Laboratories, Inc.
    FEI Number
    2915274
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 22, 2013
    Posted
    February 10, 2014
    Terminated
    March 20, 2014
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.

    Reason

    D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.

    Action

    BIO-RAD sent an Urgent Medical Device Correction letter dated November 22, 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 continue to use the affected update kit disk(s) included with the reorder pack(s), but manually track the number of injections on the cartridge, reviewing QC results closely throughout the life of the reorder pack or destroy the affected disk(s) included with these reorder pack(s) and replace with the new Update Kit disk(s) The new Update Kit disks will elminate the problem and may be used with all reorder packs. The replacement disks do not contain reagent or calibrator information; after installing teh new Update Kit disk, they ust manually update the component information using instructions provided with the disk. For questions regarding this recall call 510-741-6265.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.

    Quantity

    2906 kits (318 Kits in US; 2588 kits internationally)