BEUDAMED
    FDA Enforcement Class II Terminated

    Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

    Recall: Z-1785-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1785-2019
    Event ID
    82400
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 26, 2019
    Initiation Date
    March 11, 2019
    Classification Date
    June 14, 2019
    Termination Date
    May 15, 2020
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

    Reason

    Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.

    Code Info

    lots 4243CK, 4244CK, 4245CK.

    Distribution

    Product distributed to CA, DE, WV, and Puerto Rico.

    Quantity

    11420 kits