BEUDAMED
    FDA Recall Terminated

    uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.

    Recall: Z-1831-2013 · Initiated April 30, 2013

    Recall

    Recall Number
    Z-1831-2013
    Event Number
    65084
    Firm
    Wako Life Sciences, Inc.
    FEI Number
    3005625991
    Product Code
    DCF
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 30, 2013
    Posted
    July 30, 2013
    Terminated
    August 19, 2013
    Address
    1025 Terra Bella Ave, Mountain View, CA, 94043-1829

    Description

    uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.

    Reason

    Product fails to meet the accuracy at the low end of the measuring range.

    Action

    Wako Life Sciences, Inc. sent an email and issued a Recall Notice letter via FED EX on April 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue the use of these kits, fill out the attached RMA form, and return unused kits using Wako's FedEx account (provided on RMA form). Partially used reagent cartridges should be disposed of according to your local and state requirements. Wako Life Sciences will relplace your existing stock of uTASWako DCP kits with kits from a different log number that has been tested and has shown to not be affected. If you have any questions regarding the Recall, please submit your inquiries to [email protected] or call 443-535-0702.

    Distribution

    Distribution to CA, GA, MN, NC, UT and the District of Columbia.

    Quantity

    36 cartridges -100 tests per cartridge