Abbott Laboratories Inc

12 devices in the database

  • Model / Serial
    List Number 3P25-26 Lot Number 56940UI00
  • Product Description
    IVD, Reagent for Stat HsTN I
  • Model / Serial
    List Numbers: 6C29-20 and 6C29-25 Lot Numbers: See Attachment
  • Product Description
    IVD, Reagent
  • Model / Serial
    List Number 2K41-28, Lot 74264UN11
  • Product Description
    Reagents
  • Model / Serial
    List Number 3L52 (all lots) For lot number see attached
  • Product Description
    IVD, ARCHITECT 25-OH Vitamin D
  • Model / Serial
    List Number: 2K91-27, 2K91-20, 2K91-25 Lot Number: 08849M500, 08851M500, 08852M500, 08853M500, 10122M500, 10040M500
  • Product Description
    IVD, Reagent Kit
7 more

4 manufacturers with a similar name

Learn more about the data here

  • 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
    NZMMDSA
  • Manufacturer Address
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA
  • 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.
  • Manufacturers representative
    Abbott Diagnostics Division, Jeddah, (02) 651-1077
  • Source
    SFDA
  • 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.
  • Manufacturers representative
    Gulf Medical Co., Jeddah, (02) 6512828
  • Source
    SFDA