ARCHITECT Toxo IgM

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
    HSAHSA

13 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Manufacturer
  • Model / Serial
    List Number (LN): 6C20-25, 6C20-35 . Lot Number: 64245LI00, 66063LI00, 67003LI00, 68443LI00, 69252LI00, 70171LI00, 64248LI00, 66066LI00, 67006LI00, 68444LI00, 69253LI00, 70174LI00
  • Product Description
    Reagent, IVD
  • Manufacturer
  • Model / Serial
    6C20-25 64245LI00 2017-04-12 Not Applicable 66063LI00 2017-05-13 67003LI00 2017-05-12 68443LI00 2017-07-19 69252LI00 2017-07-19 70171LI00 2017-08-26 6C20-35 64248LI00 2017-04-12 66066LI00 2017-05-13 67006LI00 2017-05-12 68444LI00 2017-07-19 69253LI00 2017-07-19 70174LI00 2017-08-26
  • Manufacturer
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