BEUDAMED
    FDA Recall Terminated

    DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28.

    Recall: Z-0922-2010 · Initiated December 16, 2009

    Recall

    Recall Number
    Z-0922-2010
    Event Number
    54124
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LFX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 16, 2009
    Posted
    March 2, 2010
    Terminated
    March 29, 2012
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28.

    Reason

    DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed patient test results.

    Action

    Consignees were sent a DiaSorin Customer Notification letter dated December 16, 2009. The Letter was addressed to Customer. The letter described the product and the problem and indicated a replacement product will be provided. Requested consignees to complete the acknowledgement receipt form. For questions or concerns please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.

    Distribution

    US distribution: CA, CT, MA, MD, IL, OR

    Quantity

    10 kits