BEUDAMED
    FDA Enforcement Class II Ongoing

    Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

    Recall: Z-1547-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1547-2020
    Event ID
    85030
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    February 18, 2020
    Classification Date
    March 20, 2020
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

    Reason

    The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

    Code Info

    Lot 306UL

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.

    Quantity

    186 total, 27 USA