BEUDAMED
    FDA Enforcement Class II Terminated

    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    Recall: Z-1078-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1078-2017
    Event ID
    75818
    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
    February 1, 2017
    Initiation Date
    November 29, 2016
    Classification Date
    January 23, 2017
    Termination Date
    July 6, 2017
    Address
    70 Watts Ave, N/A, Charlottetown, N/A, N/A, Canada

    Description

    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    Reason

    Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

    Code Info

    Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515

    Distribution

    Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka

    Quantity

    774 Liters bulk and 565 kits