Device Recall BCS(R) Behring Coagulation System

  • 모델명 / 제조번호(시리얼번호)
    Device catalog No. OVIO03 (not lot specific)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including the states of: AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MD, MA, MI, MS, MN, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV, and WI and the countries of: Australia, France, Canary Islands, Spain, Belgium, Germany, Switzerland, Netherlands, Italy, Guadeloupe, Ceuta, Austria, Slovenia, Croatia, Saudi Arabia, Turkey, Greece, and San Marino.
  • 제품 설명
    BCS(R) Behring Coagulation System, Device catalog No. OVIO03 || Product Usage: || Multipurpose system for In Vitro coagulation studies
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
  • Source
    USFDA