Events

Alerta De Seguridad para COMMERCIAL NAME: Etest Family (ETEST ERTAPENEM) - Registration No. 10158120623 - Risk Class 2 (products of medium risk to the individual and / or low risk to public health, subject to registration) # LOTS: 2002110560; 1002389880; 1002054430 # TECHNICAL NAME: DEVICE FOR IDENTIFICATION / ANTIBIOGRAM OF MICROORGANISMS

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomérieux do Brasil S.A.; Biomerieux La Balme Led Grottes.

¿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
    1381
  • Fecha
    2014-04-24
  • 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
    According to the company, the problem can be detected using the quality control of the kit, as directed by the E-test leaflet. Contact the company that holds the registration in Brazil by phone: (21) 2444-1415
  • Causa
    Minimum inhibitory concentration (ibc) results out of the specifications for some strains of control of kit quality, ie above the highest minimum inhibitory concentration. thus, overestimation of mic for enterobacteriaceae and non enterobacteriaceae may occur (these for quality control purposes). consequences: 1. for strains "non-enterobacteriaceae", the change in mic over time may be greater than a dilution when compared to mic obtained initially (at the time of batch release). 2. for enterobacteriaceae strains, overestimation of mic may alter the result of the isolate category with mic up to or near the cut bridge. isolates of 0.5æg / ml can be interpreted as intermediates rather than sensitive. and those with a mic of 1ug / ml can be interpreted as resisting rather than intermediary. the current cutoff point of csli and eucast is 0.5ug / ml.
  • Acción
    Collection of the product under risk in Brazil.

Device

COMMERCIAL NAME: Etest Family (ETEST ERTAPENEM) - Registration No. 10158120623 - Risk Class 2 (pr...

Manufacturer

Biomérieux do Brasil S.A.; Biomerieux La Balme Led Grottes