ARCHITECT B12

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
    LAANSM

9 devices with a similar name

Learn more about the data here

  • Model / Serial
    List 6C09-20, lots 11002M300, 11003M300, 16051M200, 18288M300; List 6C09-25, lots 11002M301, 16051M201, 18288M301
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan.
  • Product Description
    ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany
  • 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
    - 7K61-35 lot 53921UI00 (Expiry 20 March 2016) - 7K61-25 lot 50957UI00 (Expiry 17 January 2016) - 7K61-35 lot 50956UI00 (Expiry 17 January 2016) - UDI Number- Not applicable
  • Product Description
    IVD, Reagent
  • Manufacturer
  • Model / Serial
    List Number (LN): 7K61‐35 Lot Number: 91345UI00 UDI: N/A
  • Product Description
    IVD Test Reagent/Kits
  • Manufacturer
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