BEUDAMED
    FDA Enforcement Class III Terminated

    Assayed Bovine Multi-Sera Level 1, Model No. AL1027

    Recall: Z-2207-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2207-2019
    Event ID
    83153
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2019
    Initiation Date
    June 10, 2019
    Classification Date
    August 7, 2019
    Termination Date
    June 16, 2020
    Address
    Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, N/A, United Kingdom

    Description

    Assayed Bovine Multi-Sera Level 1, Model No. AL1027

    Reason

    The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

    Code Info

    205SL

    Distribution

    Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.

    Quantity

    4 kits (US)