BEUDAMED
    FDA Enforcement Class III Terminated

    Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.

    Recall: Z-2557-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2557-2019
    Event ID
    83592
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 2, 2019
    Initiation Date
    July 25, 2019
    Classification Date
    September 23, 2019
    Termination Date
    December 3, 2020
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.

    Reason

    Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.

    Code Info

    Lot: 1020UC Exp. Date: 28 May 2020

    Distribution

    US Nationwide distribution including the states of IN, WV.

    Quantity

    1 kit