BEUDAMED
    FDA Enforcement Class III Terminated

    RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

    Recall: Z-0367-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0367-2020
    Event ID
    84007
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 20, 2019
    Initiation Date
    September 23, 2019
    Classification Date
    November 13, 2019
    Termination Date
    May 7, 2020
    Address
    Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, N/A, United Kingdom

    Description

    RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

    Reason

    Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.

    Code Info

    Catalogue number: FA115 GTIN: 05055273203066 Batch/Lot: 485343 Exp: Mar 2019

    Distribution

    WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW

    Quantity

    212 (19 US; 193 OUS)