BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

    Recall: Z-2815-2015 · Reported September 30, 2015

    Enforcement

    Recall Number
    Z-2815-2015
    Event ID
    72044
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2015
    Initiation Date
    August 24, 2015
    Classification Date
    September 23, 2015
    Termination Date
    May 23, 2016
    Address
    2 Edgewater Dr, N/A, Norwood, MA, 02062-4637, United States

    Description

    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

    Reason

    RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

    Code Info

    Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, Albania, Austria, Australia, Bosnia Herzeg., Bangladesh, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Denmark, Estonia, Spain, Finland, France, Great Britain, Georgia, Greece, Croatia, Hungary, Ireland, India, Italy, Lithuania, Luxembourg, Latvia, Macedonia, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Paraguay, Romania, Sweden, Singapore, Slovenia, Slovakia, Turkey, Taiwan, South Africa, Unit.Arab Emirates

    Quantity

    982 cartridges