BEUDAMED
    FDA Enforcement Class II Terminated

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    Recall: Z-1171-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1171-2016
    Event ID
    73129
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sekisui Diagnostics P.E.I. Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    January 22, 2016
    Classification Date
    March 14, 2016
    Termination Date
    August 9, 2016
    Address
    70 Watts Ave, Charlottetown, N/A, Canada

    Description

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    Reason

    Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover

    Code Info

    Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294

    Distribution

    Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.

    Quantity

    14,407 kits.