Architect Intact PTH Assay

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
    BAM

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    ARCHITECT Intact PTH Assay List Number 8K25 (see attached for impacted lots) Reagents (8K25-20, 8K25-25, 8K25-27), Calibrators (8K25-01) and Controls (8K25-10). More information on the affected products is provided in the attached letter
  • Product Description
    ARCHITECT Intact PTH assay reagent and calibrator
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Laboratories ARCHITECT Intact PTH Assay
  • Manufacturer
  • Model / Serial
  • Product Description
    ARCHITECT Intact PTH Assay, Reagents (8K25-20, 8K25-25, 8K25-27), Calibrators (8K25-01) and Controls (8K25-10)
  • Manufacturer
  • Model / Serial
  • Product Description
    ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls
  • Manufacturer
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