BEUDAMED
    FDA Enforcement Class II Terminated

    Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

    Recall: Z-1296-2019 · Reported May 15, 2019

    Enforcement

    Recall Number
    Z-1296-2019
    Event ID
    81861
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2019
    Initiation Date
    August 28, 2018
    Classification Date
    May 8, 2019
    Termination Date
    September 23, 2020
    Address
    1921 Hurd Dr, N/A, Irving, TX, 75038-4313, United States

    Description

    Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

    Reason

    There is a potential to generate falsely elevated serum or plasma chloride results when using the product.

    Code Info

    Lot No. 180326, Exp. 12/26/2018; UDI (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399

    Distribution

    Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS, NJ, NY, PA, SC, TX, VT, WA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Australia, China, Hong Kong, and New Zealand.

    Quantity

    99 modules/kits