BEUDAMED
    FDA Recall Terminated

    Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668

    Recall: Z-0638-05 · Initiated February 14, 2005

    Recall

    Recall Number
    Z-0638-05
    Event Number
    31228
    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 #114668

    Reason

    An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A curve can not be calculated from this data.

    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

    MA, Spain, Germany & Belgium

    Quantity

    31 kits