Events

Safety Alert for AxSYM CA15-3 MASTER Calibrator no. List 3B42-30, Lot no. 86504M300. CA15-3 STANDARD Calibrator no. List 9C08-01, Lot no. 88127M100, Reg. Anvisa no. 10055311039

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
    712
  • Date
    2003-03-28
  • 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
    The company informs: That it is conducting research to determine the cause. The supply is standardized as other batches of CA 15-3 gauges were unaffected and available in stock. Any questions please contact the Customer Service Center (0800-119099).
  • Reason
    Abbott laboratories - dignity division has identified that calibrators ca 15-3 (axsym ca15-3 master calibrator no. list 3b42-30, lot no. 86504m300 ca15-3 standard calibrator no. list 9c08-01, lot no. 88127m100) may cause a decrease of values ​​for the ca15-3 high control and for patient samples. these lower values ​​can have the following effects: - there is possibility of obtaining lower or out of control values ​​of the instructions for use, causing an invalid test.- patient results can be decreased by about 6.5 - 7.4 %. this small change should not affect patient management.
  • Action
    -Identify if there is in your stock the said product. - Discontinue use of these. -Preply the response protocol, for later return and bonus of the product. -Recall the CA 15-3 test using a different calibrator batch. -You may need to re-establish control strips when using a new batch of calibrators.

Device

AxSYM CA15-3 MASTER Calibrator no. List 3B42-30, Lot no. 86504M300. CA15-3 STANDARD Calibrator no...

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA