Events

Alerta De Seguridad para COMMERCIAL NAME: IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR TROPONIN I - REGISTRATION NUMBER: 10132590479 / LOTS: 3151 E 3170

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Ortho Clinical 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
    869
  • Fecha
    2007-05-11
  • 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 there is record of import and distribution of affected lots, and that the company has already started the collection process with its customers and that all affected products found in stock were blocked for sale and transferred to the quarantine site. which has already identified all the products located in stock and customers, for which the products in were sent, already having been sent the notice of collection. The UTVIG - Technovigilance Unit will be monitoring the entire collection process.
  • Causa
    The ability of certain product units to provide negatively tendentious results at concentrations below 0.20ng / ml (μg / l), this failure may be reflected in negatively tending results that affect both patient samples and positive control fluid from low level. patients with very low concentrations of troponin i may be negatively tendentious and reported incorrectly as lower than the upper reference limit (url) of 0.08ng / ml (μg / l). results greater than 0.2 ng / ml (μg / l) are not affected by this failure.
  • Acción
    Statement of recollection; Request to customers to discard the remaining inventory of the lots in question.

Device

COMMERCIAL NAME: IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR TROPONIN I - REGISTRATION NUMBER: 1013...

Manufacturer

Ortho Clinical Diagnostics