Events

Safety Alert for Trade name: ADVIA CENTAUR CA 19-9 Technical name: ANTIGEN CA 19-9 Registration number ANVISA: 10345161747 Hazard class: III Affected model: Kit for 50 tests; 250 test kit Serial numbers affected: 94990382, 39741386, 51303388, 82030380, 86322380, 6712382, 39742386, 48671388, 51673388, 60175390, 33687386, 80293380, 87147380

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC.

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
    2083
  • Date
    2016-11-18
  • 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
    For clients who use the CA 19-9 trial in the ADVIA Centaur CP and ADVIA Centaur / XP / XPT systems alternately, a review of patient outcomes generated over the past three months is recommended. Customers should not use the ADVIA Centaur XP / XPT and ADVIA Centaur CP Systems together to generate CA 19-9 results for patient monitoring. Serial patient monitoring can continue as long as the system is used independently.
  • Reason
    The advia centaur cp assay ca 19-9 does not meet the correlation with the ca 19-9 assay of the advia centaur / xp / xpt systems as mentioned in the instructions for use. advia centaur cp generates lower results for patient samples. correlation and bias between systems can be verified in customer notification. with quality control material and external quality assessment material, customers may observe a bias in which the results of the ca 19-9 advia centaur cp test are higher than the results of the ca 19-9 advia centaur / xp / xpt.
  • Action
    Field Action Code CC 16-02 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: ADVIA CENTAUR CA 19-9 Technical name: ANTIGEN CA 19-9 Registration number ANVISA: 103...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA