BEUDAMED
    FDA Enforcement Class II Terminated

    RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.

    Recall: Z-2928-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2928-2018
    Event ID
    80516
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    July 16, 2018
    Classification Date
    August 24, 2018
    Termination Date
    June 23, 2020
    Address
    500 Gbc Dr Ms 514, Po Box 6101, Newark, DE, 19702-2466, United States

    Description

    RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.

    Reason

    Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.

    Code Info

    All units affected

    Distribution

    Nationwide distribution. Worldwide foreign distribution.

    Quantity

    10199