Alerta De Seguridad para VITROS * FOR PHENITOIN PHYT Technical Name: PHENYTOIN ANVISA Registration Number: 10132590219 Hazard Class: II Affected Model: VITROS * DRY REACTIVE FOR PHYTENIN PHENITOIN 5 cartridges with 18 slides VITROS Chemistry Products PHYT Slides , product code 8298671, lots: 1401566241, 1401566904, 1401577639, 1401578552, 1401578552, 1401580410, 1401589627, 1401591230, 1401592935, 1401604105 and 1401614738. The Assay Data Diskette (ADD) and Calibration 16607 products are not applicable.

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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Some instructions are recommended: 1) Install the Calibration Diskette / ADD DRV 5910 or later diskette in the system: The automatic download will be available for the e-Connected systems as of December 2, 2016; The Calibration Diskette and / or ADD diskette will also be sent to your installation upon availability. IMPORTANT NOTE: After charging the DRV 5910 (or later) for the first time, VITROS PHYT Slides will lose calibration and recalibrate. In the meantime, it is acceptable to continue using the product. 2) After successful calibration and quality control evaluation, it is acceptable to use existing inventory of VITROS PHYT Slides. 3) Place this notification on the VITROS System or along with the user documentation. 4) Fill out and return the Receipt Confirmation Form.
  • Causa
    This notice provides additional information from a product correction notification that ortho clinical diagnostics (ortho) issued in december 2015 regarding clarification of the operator's actions for laundering errors. since then, the occurrence of u90-382 or 6lu condition codes associated with wash errors has been monitored and an increase in wash errors has been observed for vitros chemistry products phyt slides.
  • Acción
    Field Action Code 16000169 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.