Events

Safety Alert for In Vitro Diagnostic Kit ADVIA CENTAUR PRGE, Hazard Class II, Record: 10345160327. Serial numbers: 42564268; 4,262,128; 4,383,326; 4,2565,268; 42624268; 4,343,826; 4,2590,268; 4,374,228; 44847268.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; 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
    1532
  • Date
    2015-02-26
  • 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
    Samples with values ​​lower than 30ng / mL did not demonstrate bias.
  • Reason
    Confirmed the presence of positive bias when the sample results are higher than 30ng / ml when compared to master curve in the use of the advia centaur progesterone kit.
  • Action
    The company advises that the use of the progesterone kit should not be discontinued. In samples with a result higher than 30ng / mL, they should be diluted and there is no special action for results lower than that. Check instructions for how to edit the test linearity checkpoint in the ADVIA Centaur Operator's Manual to indicate that the sample should be diluted. The company asks clients to complete the Effective Field Action Verification Form (APPENDIX).

Device

In Vitro Diagnostic Kit ADVIA CENTAUR PRGE, Hazard Class II, Record: 10345160327. Serial numbers:...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA