BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOSOH AIA REAGENTS

    MDR report key: 2627811 · Received December 8, 2009

    Report

    Report Number
    3004529019-2009-00006
    Event Type
    Other
    Date Received
    December 8, 2009
    Date of Event
    October 16, 2009
    Report Date
    October 20, 2009
    Manufacturer
    TOSOH HITEC INC.
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) .

    Description of Event or Problem · 1

    UNAUTHORIZED OFFERING FOR SALE OF TOSOH BIOSCIENCES INC. (TBI) REAGENTS. WILLFULLY OBSCURING THE HANDLING AND STORAGE CONDITIONS AS WELL AS OBSTRUCTING TBI¿S RECALL PROTOCOL THROUGH THESE ACTIONS. ITEMS OFFERED INCLUDE TUMOR MARKERS, CARDIAC MARKERS, METABOLIC MARKERS, THYROID MARKERS AND REPRODUCTIVE MARKERS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSOH AIA REAGENTS AUTOMATED IMMUNOASSAY REAGENTS KHO TOSOH HITEC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other