BEUDAMED
    FDA Enforcement Class II Terminated

    Liquid Cardiac Control, CQ5053

    Recall: Z-0382-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0382-2019
    Event ID
    81159
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 14, 2018
    Initiation Date
    October 2, 2018
    Classification Date
    November 2, 2018
    Termination Date
    May 30, 2019
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    Liquid Cardiac Control, CQ5053

    Reason

    Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.

    Code Info

    All lots

    Distribution

    Distributed to IN, NY, PR, and WV.

    Quantity

    2108