Events

Safety Alert for ADVIA Centaur HIV Ag / Ab Combo Assay (CHIV), registration 10345161863, risk class IV, Lots: 73544070; 75980070; 76675070; 78024070; 79139070.

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
    1760
  • Date
    2015-11-26
  • 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
    The record holder reports that calibration failures or QC results outside the range may lead to a time delay of the result for the CHIV.
  • Reason
    Calibrations failures of the hiv ag / ac combo (chiv) assay of advia centaur systems (lots of kits mentioned in portuguese letter cn cc 15-27) due to inaccuracy in the low calibrator. an invalid calibration status prevents chiv results from being reported. siemens confirmed that due to a sporadic increase in relative light units (rlus), inaccuracy was observed with the low calibrator, negative qc material or negative samples, however, the clinical usefulness of the assay was not affected.
  • Action
    The company that owns the registry does a complement of the instruction of use and clarifies that the clients can continue using the tests, therefore the clinical utility of the same one is not affected. In this case, two guidelines are given: If a valid calibration is not obtained, contact your local or company representative for technical assistance and reagent replacement. If a valid calibration has been processed with the CHIV kit lots described in this form and the quality control results are within the range, reporting of patient outcomes can be performed. //// Field action code: CN CC 15-27.

Device

ADVIA Centaur HIV Ag / Ab Combo Assay (CHIV), registration 10345161863, risk class IV, Lots: 7354...

Manufacturer

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