Events

Safety Alert for ACCU-CHEK AVIVA METERS .. THIS PRODUCT DOES NOT HAVE REGISTRATION AT ANVISA.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnostics.

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
    821
  • Date
    2006-01-16
  • 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
    UNTIL THIS DATE DOES NOT INCLUDE REGISTRATION OF THE PRODUCT IN BRAZIL. ANVISA CONTACTS THE COMPANY ROCHE DIAGNÓSTICA BRASIL LTDA, WHICH HAS INFORMED THAT THE PRODUCT ACCU-CHEK AVIVA METERS IS SOLD ONLY IN THE FOLLOWING COUNTRIES: UNITED STATES, CANADA, DENMARK, NORWAY, SWEDEN, BELGIUM, LUXEMBOURG, HOLLAND, GERMANY, SWITZERLAND, UNITED KINGDOM , SPAIN, PORTUGAL, ITALY AND GREECE.
  • Reason
    According to the fda website (http://www.Fda.Gov/opacom/enforce.Html), roche diagnostics has issued a voluntary worldwide recall of certain product series accu-chek aviva meters , due to a potential risk of electronic malfunction of the product, which may cause errors in results or an interruption and may no longer be possible to use. the numbers of affected series marketed in the united states include: from 52500000000 to 52510999999. the recall does not apply to meters with n. of series 52511000000 or greater, as well as accu-chek aviva test strips meters. this information is available on the accu-chek website http://www.Accu-chek.Com/us/rewrite/generalcontent/en_us/article/accm_general_article_3072.Htm outside the united states, the collection includes no. from series 52600000000 to 52610999999, 52700000000 to 52710999999; and 52800000000 to 52810999999.
  • Action
    According to the information on the FDA website, ROCHE DIAGNOSTICS has contacted customers who have received units from the affected product series in different countries and is already making the due payment.

Device

ACCU-CHEK AVIVA METERS .. THIS PRODUCT DOES NOT HAVE REGISTRATION AT ANVISA.

Manufacturer

Roche Diagnostics
  • Source
    ANVSANVISA