Events

Safety Alert for ADVIA Centaur HIV 1/0/2 Enhanced (EHIV), registry: 10345161854, risk class IV; series: 44563141; 4,550,2141; 47542143; 4,844,414; 5,146,245; 52901147.

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
    1592
  • Date
    2015-05-22
  • 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
    According to the manufacturer, the probability of reporting an erroneous result (reactive or non-reactive) is unlikely, as this can be detected by quality control. The results of patients obtained with this assay are acceptable if they are followed by valid quality control results.
  • Reason
    Product quality control results out of the expected range. the registry subject relates the issue to the decrease in onboard stability of the ehiv assay reagent.
  • Action
    The company will perform an update / correction of the instructions for use. Guidance is that if quality control results are not out of the expected ranges, no action is required. If quality control results are obtained outside the expected range, it is recommended that: a. Recalibrate the test every 7 days; B. Replace the reagent cartridge every 14 days. MORE INFORMATION IN THE LETTER TO THE CLIENT ATTACHED

Device

ADVIA Centaur HIV 1/0/2 Enhanced (EHIV), registry: 10345161854, risk class IV; series: 44563141; ...

Manufacturer

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