BEUDAMED
    FDA Recall Terminated

    VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.

    Recall: Z-1984-2011 · Initiated April 14, 2010

    Recall

    Recall Number
    Z-1984-2011
    Event Number
    55910
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    GKA
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    April 14, 2010
    Posted
    April 14, 2011
    Terminated
    August 8, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.

    Reason

    The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed.

    Action

    Bio-Rad Laboratories sent out the Urgent Medical Device Correction notice on 4/14/2011, by Federal Express. An Update was sent on May 13th, advising customers of a minor discrepancy in the parameters included on the affected Resin Update CD-ROMs. Customers were instructed to examine your inventory for the affected reorder pack lots. Please complete and return the Medical Device Correction Response Form Questions regarding this recall please call (510) 724-6114.

    Distribution

    Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.

    Quantity

    658 units