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

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.

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.