Events

Safety Alert for ADVIA CENTAUR HBsAgII (HBsII), Registration 10345161861, Lot 56167056

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
    1692
  • Date
    2015-09-21
  • 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
    Siemens Healthcare has identified that an "Invalid" result from positive quality control delays the release of positive samples from patients during the confirmatory test.
  • Reason
    Siemens healthcare diagnostics has identified an error on the advia centaur confirmation card which is included in the advia centaur hbsagii kit. the error is interpreted as "invalid" and a "conf n / a" flag appears when the positive control of hbsagii is tested in the confirmatory assay hbsagii.
  • Action
    The company informs that lot 56167056 of ADVIA Centaur / ADVIA Centaur XP and ADVIA Centaur XPT can be used to generate HBsAgII assay results, however, an alternative lot or method should be used if there is a need to report positive results using the assay ADVIA Centaur conf.

Device

ADVIA CENTAUR HBsAgII (HBsII), Registration 10345161861, Lot 56167056

Manufacturer

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