Safety Alert for GLYCOMETERS ACCU-CHECK ADVANTAGE (1) MODEL I, (2) MODEL II, (3) VOICEMATE ACCU-CHECK SYSTEMS.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    15
  • Date
    2001-05-14
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Unit software causes data storage errors in specific circumstances. if the user tests when the watch records 12 hrs, midday or midnight, the apparatus mark 1 day of the 7 day cycle and the test is icorretamentally warm.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE ROCHE DAGNOSTIC URGENT CORRECTION LETTER ON MARCH 30, 2001. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT DAGNOSTIC ROCHE ON THE PHONE.