• Model / Serial
    Product List Number: 6E58 (US) Version 22.01and 6E59 (WW) Version 23.0 and lower, all serial numbers.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution -- United States including Puerto Rico and Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay and Venezuela.
  • Product Description
    ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower. || The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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