Events

Alerte De Sécurité sur ACCU-CHEK AVIVA METERS .. THIS PRODUCT DOES NOT HAVE REGISTRATION AT ANVISA.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Roche Diagnostics.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    821
  • Date
    2006-01-16
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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