Events

Safety Alert for ADVANTAGE II, TESTS WITH TAPES FOR GLUCOSE. ALL LOTS BEGINNING WITH NUMBER LESS THAN 445.

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
    80
  • Date
    2001-05-04
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    BRAZIL 06 / JULY / 2001 - COMFORT STRIP VERSION (BRAZIL) UNTIL THIS DATE NO REGARDLED OCCURRENCE VERSION CONFORT TURBO WAS NOT AND IS NOT STILL MARKETED IN BRAZIL. IT FURTHER INFORMES THAT ROCHE DIAGNOSTICS IS DEVELOPING A NEW VERSION OF THE TURBO CONFORT STRIP THAT WILL NOT PRESENT THE PROBLEM OF CONFLICT WITH THE MONITOR ADVANTAGE COMPLETE. THIS UPDATED VERSION OF STRIPS THAT WILL NOT PRESENT CONFLICT WITH THE COMPLETE ADVANTAGE WILL HAVE LOT NUMBERS STARTING WITH 445 XXX.
  • Reason
    The complete advantage glycometer, when used with the advantage ii ribbons, does not operate the alarm to notify the operator if a second blood drop must be added to the ribbon when the first is insufficient. the manufacturer began removal day, march 21, 2001.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE ROCHE REMOVAL LETTER DIAGNOSTICS ON MARCH 21, 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL THOSE AFFECTED PRODUCTS THAT ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR DISTRIBUTOR OR MANUFACTURER ON YOUR PHONE (00XX-1-317-845-2000).

Device

ADVANTAGE II, TESTS WITH TAPES FOR GLUCOSE. ALL LOTS BEGINNING WITH NUMBER LESS THAN 445.

Manufacturer

ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA
  • Source
    ANVSANVISA