Alerta De Seguridad para AEROSET® Biochemical Analyzer and Accessories - Registry Number: 10055310865

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil Ltda.

¿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
    When these error codes occur, the user is notified by changing the color of the icon in the Error Code screen. Lower level error codes (that is, level 3 error messages), as defined by the manufacturer, may have an influence on the generation of patient outcomes. Higher error code levels will cause not only the color change of the icon, but will also cause a change in the processing status of the RUNNING AEROSET Analyzer to PAUSE. The user should evaluate the error code and take the necessary steps to finalize the processing before reporting the results. There is no effect on the health or ability of the user to use the equipment. This occurrence was identified internally during the development of user needs for a next generation of AEROSET Family Member equipment on 6 February 2004. As part of the system review for continuous improvements, the error message database was the appropriate levels setting. When one of the Error Messages listed in Table 1 is generated, an "HW" Result Error Code will be generated. Until your laboratory is able to complete the actions required above, follow these steps: Customer Letter accompanied by Response Protocol for the sole AEROSET customer in Brazil. If you have any questions or concerns, please contact the Abbott Customer Service Center ¬Division Diagnostics - Telephone 0800-11-9099.
  • Causa
    The aeroset® biochemical analyzer and accessories and their software are performing performance as designed and in accordance with the product labeling. as part of an internal system review for continuous improvement, the database of error codes was revised to the levels of error codes configured on february 6, 2004. a total of 18 level 3 error codes were identified as required for reclassification to a higher level, level 1. these levels of error codes are used to determine how the equipment communicates with the end user when error messages occur.
  • Acción
    Customer Letter accompanied by Response Protocol was sent to all AEROSET customers, providing instructions to the user on how to change the status of the error codes identified in Table 2 above. These modifications to the error codes will be included in the next release of the AEROSET Analyzer Software version 1.03ER000, eliminating the need for users to manually change the status of error codes using the above mentioned instructions. The projected date for release of this software is the 4th quarter of 2004