Device Recall AxSYM

  • Model / Serial
    List no. 3B34-20
  • Product Classification
  • Distribution
    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
  • Product Description
    AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label: || AxSYM || Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
  • 1 Event

Manufacturer

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

27 devices with a similar name

Learn more about the data here

  • Model / Serial
    List Numbers: 7A83-01, 7A83-95, 7A83-98, and 7A83-03
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
  • Manufacturer
  • Model / Serial
    Product list number: 9C05-10 Lot No.: 91533Q100 Exp. date: 10/20/2003
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain
  • Product Description
    AFP Control Kit distributed under the following label: || AxSYM and IMx, Abbott Laboratories USA, North || Chicago, IL 60064
  • Manufacturer
  • Model / Serial
    list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
  • Model / Serial
    All Serial Numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
  • Manufacturer
  • Model / Serial
    all lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Uruguay.
  • Product Description
    AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
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