BEUDAMED
    FDA Enforcement Class II Ongoing

    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

    Recall: Z-1594-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1594-2024
    Event ID
    94138
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 24, 2024
    Initiation Date
    January 31, 2024
    Classification Date
    April 17, 2024
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

    Reason

    Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.

    Code Info

    GTIN: 05055273204544 (1) Batch/Lot: 602114 /1083MA-1087MA (2) Batch/Lot: 636645 /1108MA-1112MA (3) Batch/Lot: 662429 /1083MA- 1087MA

    Distribution

    US Nationwide distribution in the states of GA, MA, WV including PR.

    Quantity

    6 units