Alere Medical Co Ltd

  • 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
  • 3 Events

3 devices in the database

  • Model / Serial
    Model: , Affected: 20 Tests Kits catalogue number 7D2846, Lot number 80671K100C
  • Model / Serial
    Model: , Affected: Lot numbers, 03BDA005A, 03BDA006A, 03BDA006B, 03BDB001C
  • Model / Serial
    Model: HS0100267 HS0200431 HS0200433 HS200433SJM HS200433SJMK HS0100071 HS0100139 HS99007G1 and HS99008G1, Affected:
  • Product Classification

One manufacturer with a similar name

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