ARCHITECT Lactic Acid

Manufacturer

  • 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
    HPRA

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: , Affected: 31497UN14, 09353UN15, 45216UN15, 14596UN15, 37055UN15, 14782UN16
  • Manufacturer
  • Model / Serial
    List Number (LN): 9D89-21 Lot Numbers: 31497UN14, 09353UN15, 45216UN15, 14596UN15, 37055UN15, 14782UN16
  • Product Description
    IVD
  • Manufacturer
  • Model / Serial
  • Product Description
    In-vitro diagnostics - equipment / products for clinical chemistry
  • Manufacturer
  • Model / Serial
    31497UN14 17-Oct-2016 09353UN15 12-Feb-2017 45216UN15 12-May-2017 14596UN15 30-Jul-2017 37055UN15 12-Oct-2017 14782UN16 21-Apr-2018
  • Manufacturer
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