BIOSITE INCORPORATED

  • Manufacturer Address
    SAN DIEGO
  • 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
    HC
  • 3 Events

3 devices in the database

  • Model / Serial
    Model Catalog: 55071 (Lot serial: all serial numbers SW ver 5.02); Model Catalog: 55070 (Lot serial: all serial numbers SW ver 5.02)
  • Product Description
    Triage MeterPro
  • Model / Serial
    Model Catalog: 94400 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    TRIAGE TOX DRUG SCREEN PN 94400
  • Model / Serial
    Model Catalog: 96000 (Lot serial: 190790); Model Catalog: 96000 (Lot serial: 189158); Model Catalog: 96000 (Lot serial: 186624); Model Catalog: 96000 (Lot serial: 185593); Model Catalog: 96000 (Lot serial: 188135); Model Catalog: 96000 (Lot serial: 181471); Model Catalog: 96000 (Lot serial: 183607); Model Catalog: 96000 (Lot serial: 181472); Model Catalog: 96000 (Lot serial: 180263); Model Catalog: 96000 (Lot serial: 187303); Model Catalog: 96000 (Lot serial: 187398)
  • Product Description
    Triage C. Difficile Panel Ref# 96000

2 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
    NIDFSINVIMA
  • 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
    BAM