BEUDAMED
    FDA Enforcement Class II Terminated

    Liquid Cardiac Control CQ5053

    Recall: Z-0937-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0937-2018
    Event ID
    79035
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    August 8, 2017
    Classification Date
    March 9, 2018
    Termination Date
    September 5, 2018
    Address
    Ardmore 55 The Diamond Road, Crumlin, N/A, United Kingdom

    Description

    Liquid Cardiac Control CQ5053

    Reason

    Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.

    Code Info

    Lot 4069CK

    Distribution

    Nationally

    Quantity

    450 kits