Device Recall Siemens RAPIDLab 1245 System

  • Model / Serial
    All serial numbers.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. || The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Drive, Norwood MA 02062
  • Manufacturer Parent Company (2017)
  • Source
    USFDA