Events

Alerta De Seguridad para ACCU-CHEK AVIVA METERS .. THIS PRODUCT DOES NOT HAVE REGISTRATION AT ANVISA.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnostics.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    821
  • Fecha
    2006-01-16
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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