Abbott Point of Care

14 devices in the database

  • Model / Serial
    04J50-01, 04J50-02, 03P89-24 | R13149A, R13151, R13151A, lots from C13139 to C13270A
  • Product Description
    IVD: Prothrombin time kit
  • Model / Serial
    O4J50·01, O4J50·02, 031'89·24 | PTf1NR 10lS beginning with RI I or RI2
  • Product Description
    IVD: Prothrombin time kit
  • Model / Serial
    06F15-03, 06F15-04, 03P90-25, 600-9009-25
  • Product Description
    IVD: Troponin kit
  • Model / Serial
    03P90-25, 06F15-03, 06F15-04, 600-9009-25 | Lots beginning with letter "T", See FSN
  • Product Description
    IVD: Troponin control
  • Model / Serial
    07G01-0l, 07G01-02, 03P86-25, 600-9006-25
  • Product Description
    IVD: Activated whole blood clotting time kit
9 more

20 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 Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 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
    USFDA
  • Manufacturer Address
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520-1407
  • 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.
  • Source
    AEMPSVFOI
15 more