FreeStyle Blood Glucose Monitoring System

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
    SATP

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    For lot numbers beginning with A, B, C, D, G, H, K, and M, all lot numbers are included. All lot numbers from V-G157-31584 and below are included, and also all lot numbers Y-G018-32983 and below are included in the recall.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.
  • Product Description
    FreeStyle Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
  • Model / Serial
    FreeStyle Flash Blood Glucose Meter FreeStyle Blood Glucose Meter ………………………………... FDA update code: Part number CAT11001-0; all serial numbers Catalog Number 17002 NDC 99073-0170-02. All serial numbers ...................... MHRA update code : - FreeStyle Mini blood glucose meter - FreeStyle Navigator (Version 1.0 and 1.5)
  • Product Classification
  • Product Description
    Diabetes meter
  • Manufacturer
  • Model / Serial
  • Product Description
    IVD: Glucose rapid test system analyser; Glucose rapid test system reagent; Ambulatory insulin infusion pump
  • Manufacturer
  • Model / Serial
    Model Catalog: 81017 (Lot serial: ALL LOTS); Model Catalog: 80000 (Lot serial: ALL LOTS); Model Catalog: 11001 (Lot serial: ALL LOTS)
  • Product Description
    FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
  • Manufacturer