BEUDAMED
    FDA Recall Terminated

    Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

    Recall: Z-2575-2018 · Initiated June 8, 2018

    Recall

    Recall Number
    Z-2575-2018
    Event Number
    80475
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 8, 2018
    Terminated
    November 5, 2018

    Description

    Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

    Reason

    The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.

    Action

    On June 8, 2018, the firm issued an Urgent Medical Device Recall letter to affected consignees. The letter stated that Randox has confirmed Liquid Cardiac Control CQ5053 Lot: 4245CK is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. Customers were instructed to do the following: " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Update kits with corrected IFU's excluding Troponin T values. " Complete and return the vigilance response section of this form to [email protected] within five working days.) In addition, distributors were instructed to send a copy of the letter to all affected customers and to those who need to be aware within their organization.

    Distribution

    Worldwide Distribution - US in the state of WV. Foreign distribution to Australia, Chile, China, Germany, Hungary, Ireland, Italy, Moldova, Netherlands, Peru, Poland, Saudi Arabia, Slovakia, Spain, Sultanate of Oman, UAE, UK, and Vietnam

    Quantity

    1 kit (US), 602 kits (OUS)