FreeStyle InsuLinx Blood Glucose Monitoring System


  • 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

4 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    Press release: Safety alert over Abbott's FreeStyle InsuLinx Blood Glucose Monitoring System
  • Manufacturer
  • Model / Serial
    Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution
  • Product Description
    FreeStyle InsuLinx Blood Glucose Monitoring System: || For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. || Abbott Diabetes Care, Inc. || 1360 South Loop Road || Alameda, CA 94502 USA || The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
  • Manufacturer
  • Model / Serial
    71146-70 | 01S194F; 01S275F; 04R320F; 05R320F; 05R347F; 06R348F | all
  • Product Description
    IVD: Home-use/point-of-care blood glucose monitoring system IVD
  • Manufacturer