BEUDAMED
    FDA Enforcement Class III Ongoing

    Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640

    Recall: Z-2021-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2021-2023
    Event ID
    92344
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 5, 2023
    Initiation Date
    May 4, 2023
    Classification Date
    June 28, 2023
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640

    Reason

    Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

    Code Info

    GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23

    Distribution

    CA, IL, VA, WA, WI including PR

    Quantity

    1 kit