BEUDAMED
    FDA Enforcement Class II Terminated

    RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.

    Recall: Z-1252-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1252-2015
    Event ID
    70203
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 18, 2015
    Initiation Date
    December 30, 2014
    Classification Date
    March 6, 2015
    Termination Date
    August 2, 2017
    Address
    2 Edgewater Drive, N/A, Norwood, MA, 02062, United States

    Description

    RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.

    Reason

    Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

    Code Info

    All serial numbers.

    Distribution

    Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.

    Quantity

    3420 devices