Events

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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA.

¿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
    80
  • Fecha
    2001-05-04
  • 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
    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.
  • Causa
    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.
  • Acción
    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