BEUDAMED
    FDA Enforcement Class II Terminated

    Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.

    Recall: Z-0414-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0414-2020
    Event ID
    84044
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 27, 2019
    Initiation Date
    October 4, 2019
    Classification Date
    November 15, 2019
    Termination Date
    July 6, 2020
    Address
    Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, N/A, United Kingdom

    Description

    Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.

    Reason

    Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.

    Code Info

    Catalogue Number: CQ5053 GTIN: 05055273207460 Batch/lot: 4245CK (Exp. 28Nov2019), 4248CK (Exp. 28Nov2019), 4313CK (Exp. 28Jun2020) and 4316CK (Exp. 28Jun2020)

    Distribution

    US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,

    Quantity

    6,702