Device Recall Siemens Coagulation FIX Deficient PlasmaClotting Factor VIIIIXXIXII Deficient Plasma

  • 모델명 / 제조번호(시리얼번호)
    10454742 10454729 10461894 10470625
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Austria, Bulgaria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia, Bahrain, Belarus, Bosnia-Herzegovina, Guadeloupe, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Qatar, Russia, San Marino, Saudi Arabia, Serbia, South Africa, United Arab Emirates, Argentina, Brazil, Chile, El Salvador, Peru, China, Mexico, Canada and United States.
  • 제품 설명
    Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. || In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
  • Source
    USFDA