FreeStyle Blood Glucose Monitoring System

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    FreeStyle Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
  • Modèle / numéro de série
    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)
  • Classification du dispositif
  • Description du dispositif
    Diabetes meter
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    IVD: Glucose rapid test system analyser; Glucose rapid test system reagent; Ambulatory insulin infusion pump
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 81017 (Lot serial: ALL LOTS); Model Catalog: 80000 (Lot serial: ALL LOTS); Model Catalog: 11001 (Lot serial: ALL LOTS)
  • Description du dispositif
    FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
  • Manufacturer