BEUDAMED
    FDA Enforcement Class II Ongoing

    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

    Recall: Z-1369-2024 · Reported April 3, 2024

    Enforcement

    Recall Number
    Z-1369-2024
    Event ID
    94088
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 3, 2024
    Initiation Date
    February 14, 2024
    Classification Date
    March 22, 2024
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

    Reason

    Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

    Code Info

    GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY

    Distribution

    US Nationwide distribution in the states of CA, IN.

    Quantity

    666 units