BEUDAMED
    FDA Enforcement Class II Terminated

    Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904

    Recall: Z-0839-2019 · Reported February 27, 2019

    Enforcement

    Recall Number
    Z-0839-2019
    Event ID
    81746
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 27, 2019
    Initiation Date
    December 4, 2018
    Classification Date
    February 15, 2019
    Termination Date
    June 18, 2020
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904

    Reason

    Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.

    Code Info

    All lot codes

    Distribution

    WV, PR

    Quantity

    225 kits