Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AMPMDRS

695 devices with a similar name

Learn more about the data here

  • Model / Serial
    List number 08G98-07 for Conventional Units; List number 04J62-07 for SI Units.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand
  • Product Description
    ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
  • Manufacturer
  • Model / Serial
    All lots/serial numbers.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide. Product distributed nationwide to direct accounts (including gov''t accounts) in: AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WY. Foreign distribution to the following countries: Argentina, Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Grand Cayman, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Puerto Rico, Singapore, Thailand, Trinidad, Uruquay and Venezuela.
  • Product Description
    ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX.
  • Manufacturer
  • Model / Serial
    list 2K41-20, lot 95567G005, exp 6-30-2006
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Canada, Australia, Germany and Taiwan
  • Product Description
    ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
  • Model / Serial
    lot numbers 33079M200, 33079M201
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany and Australia
  • Product Description
    ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
  • Model / Serial
    list numbers 6C11-20, 6C11-25 and 6C11-30; all lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany, Uruguay, Japan, Singapore, Hong Kong, South Korea, Australia and New Zealand
  • Product Description
    ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
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