Events

Safety Alert for AEROSET® Biochemical Analyzer and Accessories - Registry Number: 10055310865

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    792
  • Date
    2004-04-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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

Device

AEROSET® Biochemical Analyzer and Accessories - Registry Number: 10055310865

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA