BEUDAMED
    FDA Enforcement Class III Terminated

    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

    Recall: Z-0969-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0969-2018
    Event ID
    79076
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 21, 2018
    Initiation Date
    August 11, 2017
    Classification Date
    March 12, 2018
    Termination Date
    March 29, 2019
    Address
    515 Industrial Blvd, Kearneysville, WV, 25430-2778, United States

    Description

    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

    Reason

    The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

    Code Info

    Catalog numbers: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)

    Distribution

    Distribution US nationwide.

    Quantity

    117 Kits