Alerta De Seguridad para Trade name: Chemical Efficiency Checker And Ii Vitros *. Technical Name: Combined Parameters In Same Product - Class II. ANVISA registration number: 10132590232. Class of risk: II. Affected model: 12 x 3 ml of the level I lyophilized checker; 12 x 5 ml diluent for level II verifier; 12 x 3 ml of the level II lyophilized checker; 12 x 5 ml diluent for Level I verifier. Serial numbers affected: SKU: 8231474 | Lot: K4852

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..

¿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
    Be aware that closed bottles of Batch K4852 can no longer be stored refrigerated to check the performance of VITROS AST or ASTJ Slides. Discard any remaining stock refrigerated stored if used to check VITROS AST or ASTJ Slides. Keep this notification as a verification of the revised instructions. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Instructions for use indicate that the closed vitros performance verifier ii may be stored frozen until the expiration date or refrigerated for ≤6 months. stability tests determined that the closed bottles for lot k4852 did not meet the 6-month specification of the product when stored refrigerated. all other lots are not affected. our data indicate that quality control results generated with vitros ast slides were negatively biased outside the 2 standard deviation (sd) limit for refrigerated stored closed bottles. vitros astj slides are affected in a similar way. the frozen stored product is not affected by this problem. customers can continue to use the frozen stored product until the due date.
  • Acción
    Field Action Code TC2017-132 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Field correction.