Device Recall cobas b 2212Roche OMNI S2 system

  • 모델명 / 제조번호(시리얼번호)
    3337111001 and 3337111692  UDI: 04015630018307
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA ( nationwide)
  • 제품 설명
    cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 || The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
  • Source
    USFDA