Dade Behring , Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 6 건

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 544531 to 544548 and 544502 to 544504.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped nationwide to medical facilities.
  • 제품 설명
    Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
  • 모델명 / 제조번호(시리얼번호)
    Software version 3.5
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.
  • 제품 설명
    StreamLab Analytical Workcell. General Purpose Laboratory Device.
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
  • 제품 설명
    DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
  • 모델명 / 제조번호(시리얼번호)
    Lot 540624, Lot 540625, and Lot 540626
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
  • 제품 설명
    BC Thrombin Reagent . Thrombin Time Test
  • 모델명 / 제조번호(시리얼번호)
    Lots 541428, 541429, expiration date of Nov 2006
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The heparin reagent, which is a component of a test kit, wasdistributed to direct accounts in the following states: AZ, CA, CO, FL, IA, IL, IN, KY, OH, MA, MD, MI, MN, NC, NE, NJ, NM, NY, PA,TN, TX, WI, WV. Further, there are foreign countries also affected in this recall action, as listed: Australia, Canada, France, Finland, Germany, Israel, Italy, Spain, United kingdom, Spain
  • 제품 설명
    Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
하나 더 1 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Dade Behring , Inc., 500 GBC Dr., Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Source
    USFDA