BEUDAMED
    FDA Enforcement Class II Terminated

    ABL800 analyzer, model numbers 393-800 and 393-801.

    Recall: Z-0682-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0682-2019
    Event ID
    81547
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    July 3, 2018
    Classification Date
    December 22, 2018
    Termination Date
    August 30, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    Description

    ABL800 analyzer, model numbers 393-800 and 393-801.

    Reason

    The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

    Code Info

    Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.

    Distribution

    Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.

    Quantity

    2,131 analyzers