BEUDAMED
    FDA Enforcement Class II Terminated

    AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

    Recall: Z-3237-2017 · Reported October 11, 2017

    Enforcement

    Recall Number
    Z-3237-2017
    Event ID
    78097
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 11, 2017
    Initiation Date
    September 7, 2017
    Classification Date
    September 29, 2017
    Termination Date
    August 1, 2019
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

    Reason

    Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92  5.85 kPa or 36.9  46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)

    Code Info

    S7745 Lot R0698

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.

    Quantity

    1669 Boxes