Events

Alerta De Seguridad para ETEST FAMILY - CEFOTAXIME - 100TIRAS, REGISTRATION 10158120623, CLASS OF RISK II, LOT 1002377890 (VALID 06/06/2015)

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

¿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
    1648
  • Fecha
    2015-07-24
  • 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, Quality Control has failed because a strain expected to be susceptible to the antibiotic appears to be resistant. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • Causa
    Internal failure in quality control. identified a deviation of performance associated with the quality control test from retained product samples, resulting in results outside the specification of resistant strains.
  • Acción
    The company will not send the letter to the customer once the unit of the batch marketed, at the time of the investigation, had its expiration date. If the customer has performed quality control tests and presented result accordingly, the strips can be considered safe.

Device

ETEST FAMILY - CEFOTAXIME - 100TIRAS, REGISTRATION 10158120623, CLASS OF RISK II, LOT 1002377890 ...

Manufacturer

Biomerieux Brasil SA.; Biomerieux S.A