Events

Alerta De Seguridad para VITROS® Chemistry Products Calibrator Kit 9, Lot SKU 8568040 - 0954

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
    1721
  • Fecha
    2015-10-27
  • 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
    The company informs that when condition code U90-382 or 6LU occurs, the VITROS® System hides the result and it is not reported. The increase in condition codes occurs mainly when using the VITROS® DGXN and PHYT Slides. All numerical results obtained are valid provided that no wash error has occurred and the quality control results are within acceptable limits.
  • Causa
    The manufacturer has identified a potential increase in condition codes u90-382 or 6lu (washing errors) when using the product vitros® calibrator kit 9, lot 0954.
  • Acción
    The company is instructed to discontinue use of the product and discard all remaining inventory of VITROS® Calibrator Kit 9, Lot 0954 after receiving your replacement request. NOTE: It is acceptable to use Lot 0954 until your replacement request arrives. Recalibrate the VITROS® DGXN and PHYT Slides using the Cal Kit 9 in your installation, with an alternative batch of the calibrator, if available. Place this notification on each VITROS® System or along with the user documentation. Fill out and return the Receipt Confirmation Form. Further information: Annex I

Device

VITROS® Chemistry Products Calibrator Kit 9, Lot SKU 8568040 - 0954

Manufacturer

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