Events

Safety Alert for Product name: Dimension EXL TNI Flex Technical name: TROPONIN Registration number ANVISA: 10345161707 Hazard class: III Model affected: 144 tests (4x36) Serial numbers affected: All lots

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
    2278
  • Date
    2017-04-25
  • 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 does not recommend retroactive analysis of results based on this occurrence.
  • Reason
    Siemens healthcare diagnostics has confirmed that the biotin concentrations listed in the non-interfering substances section of the current troponin assay instructions for use (ifu) report incorrect units as well as incorrect levels of biotin interference. in the tni assay there is significant interference at levels incorrectly stated in current ifus.
  • Action
    Field Action Code VC 17-04 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify customers.

Device

Product name: Dimension EXL TNI Flex Technical name: TROPONIN Registration number ANVISA: 1034516...

Manufacturer

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