BEUDAMED
    FDA Recall Terminated

    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.

    Recall: Z-3118-2017 · Initiated July 20, 2017

    Recall

    Recall Number
    Z-3118-2017
    Event Number
    77896
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    LDP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 20, 2017
    Terminated
    January 4, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.

    Reason

    Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.

    Action

    The recalling firm issued letters dated 7/17/2017 via regular mail and email on 7/20/2017 to all customers receiving the affected product.

    Distribution

    Distribution US nationwide.

    Quantity

    320 units