Device Recall AxSYM

제조사

  • 제조사 주소
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Barceloneta PR 00617
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 27 건

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  • 모델명 / 제조번호(시리얼번호)
    List Numbers: 7A83-01, 7A83-95, 7A83-98, and 7A83-03
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Canada, Germany, Ireland, England, Belgium, France, Austria, Italy, Spain, Russia, Japan, Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Korea, Australia, New Zeland, Honduras, Costa Rica, Trinidad, Bahamas, Northern Antilles, Bermuda, Panama, West Indies, Paraguay, Norway, Kingstow, VC
  • 제품 설명
    AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    List no. 3B34-20
  • 의료기기 분류등급
  • 유통
    Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama
  • 제품 설명
    AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label: || AxSYM || Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product list number: 9C05-10 Lot No.: 91533Q100 Exp. date: 10/20/2003
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain
  • 제품 설명
    AFP Control Kit distributed under the following label: || AxSYM and IMx, Abbott Laboratories USA, North || Chicago, IL 60064
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.
  • 제품 설명
    AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Serial Numbers
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and to the following foreign locations: Mexico, Viet Nam, Venezuela, Columbia, Argentina, Chile, Japan, Austria, Denmark, France, Israel, Norway, Saudi Arabia, Spain, Turkey, India, Phillippines, Brazil, Puerto Rico, Dominicam Republic, Canada, Germany, Taiwan, Thailand, Belgium, Egypt, Greece, Italy, Poland, South Africa, Sweden, United Arab Emirates, Malaysia, Singapore, Hong Kong, Australia, New Zealand, China, Uruguay, Korea, England, Czech Republic, Finland, Hungary, Netherlands, Portugal, Eastern Europe, Switzerland, Central America, and Pakistan
  • 제품 설명
    AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
  • Manufacturer
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