BEUDAMED
    FDA Recall Terminated

    Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237*** Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.

    Recall: Z-1377-2012 · Initiated January 30, 2012

    Recall

    Recall Number
    Z-1377-2012
    Event Number
    61084
    Firm
    Wako Chemicals USA, Inc.
    FEI Number
    3005625991
    Product Code
    DFC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 30, 2012
    Posted
    April 6, 2012
    Terminated
    May 2, 2012
    Address
    1600 Bellwood Rd, Richmond, VA, 23237-1326

    Description

    Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237*** Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.

    Reason

    In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.

    Action

    Wako Diagnostics notified its customers by telephone on January 26, 2012 and sent an Urgent Medical Device Recall letter dated January 30, 2012 to inform them of the product recall. The notifications identified the affected product, problem and actions to be taken. Consignees were requested to: 1) Complete and sign the attached Return Materials Authorization (RMA) Form to receive replacement material and 2) Package the recalled Product to be returned and send to the address listed on the RMA form. For questions call Technical Support Team at 1-877-714-1924.

    Distribution

    The product had been sold to 2 customers in the US.

    Quantity

    10 kits