BEUDAMED
    FDA Recall Terminated

    LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E.

    Recall: Z-0637-05 · Initiated February 14, 2005

    Recall

    Recall Number
    Z-0637-05
    Event Number
    31167
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 14, 2005
    Posted
    March 18, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E.

    Reason

    Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values.

    Action

    DiaSorin Customer Notification dated 02/14/05 was sent to customers instructing them to destroy all kits from the affected lot number. Customers were also asked to complete and return a form indicating how many kits were destroyed.

    Distribution

    MI, NJ, Germany, Spain and Belgium

    Quantity

    131