BEUDAMED
    FDA Enforcement Class II Terminated

    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

    Recall: Z-2150-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2150-2019
    Event ID
    83155
    Classification
    Class II
    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 11, 2019
    Classification Date
    August 6, 2019
    Termination Date
    May 15, 2020
    Address
    Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, N/A, United Kingdom

    Description

    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

    Reason

    The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

    Code Info

    1306UN, 1308UN, 1309UN

    Distribution

    US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.

    Quantity

    149 (US)