BEUDAMED
    FDA Enforcement Class II Terminated

    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    Recall: Z-2965-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2965-2020
    Event ID
    86238
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RANDOX LABORATORIES, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2020
    Initiation Date
    July 30, 2020
    Classification Date
    September 14, 2020
    Termination Date
    February 3, 2021
    Address
    34 Diamond Rd, N/A, Crumlin Colorado Antrim, N/A, N/A, United Kingdom

    Description

    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    Reason

    Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.

    Code Info

    Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541

    Distribution

    US Distribution to states of: VA, UT, WV and country of : Canada

    Quantity

    143 kits in total