Events

Alerta De Seguridad para VITROS Chemistry Products UPRO Slides, Product Code: 10132590346 Hazard Class: II Affected Model: 5 Cartridges with 18 Slides Serial Numbers Affected: VITROS Chemistry Products UPRO Slides, Product Code 6800120, Generations (GENs): 12, 13, 14, 15, 16, 17, 18.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc..

¿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
    2238
  • Fecha
    2017-03-20
  • 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
    Actions required: • Immediately discontinue use and discard all remaining VITROS UPRO Slides products in your inventory. NOTE: Ortho will credit your VITROS UPRO Slides, VITROS Chemistry Products Calibrator Kit 10 and / or VITROS Chemistry Products UPRO Performance Verifier I & II credit to your account. • Place this notification next to each VITROS System that uses the VITROS UPRO Slides products or along with your user documentation.
  • Causa
    Ortho clinical disagnostics (ortho) has identified the potential for diverting results for urinary protein when using vitros upro slides products.
  • Acción
    Field Action Code TC2016-234 / 16000189 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will collect.

Device

VITROS Chemistry Products UPRO Slides, Product Code: 10132590346 Hazard Class: II Affected Model:...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc.