Events

Safety Alert for Trade Names: Advia 1650 Chemistry System, registration 10345160453; Advia 1200 Chemistry System, registration 10345160456; Advia 2400 Chemistry System, registration 10345160471; Advia 1800 Chemistry System, registration 10345160636; Clinical Chemistry System Dimension, registry 10345161629; Clinical Chemistry System Dimension Rxl Max, registration 10345161632; Clinical Chemistry Analyzer System Dimension, registry 10345161633; Dimension EXL system, registration 10345161695; Dimension EXL 200, registration 10345161762; ADVI Chemistry XPT, registration 10345161947.

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
    1876
  • Date
    2016-04-18
  • 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
    Recommendations to Users and Patients: Siemens recommends venipuncture should be performed prior to the administration of NAC or Metamizol. Baseline values ​​prior to administration of NAC or Metamizole therapy are not affected.
  • Reason
    Siemens healthcare is alerting its customers in brazil about interferences of n-acetylcysteine ​​(nac) and metamizol and in the use of the above products, that is, in tests that use trinder reactions or principles of trinder reactions. the trinder reaction is a reaction where hydrogen peroxide formation occurs, and subsequently reacts with a derivative of phenol and aminoantipyrine, which in the presence of peroxidase, forms a colored quinone product. siemens has confirmed that falsely diminished results may occur in samples collected from patients receiving n-acetylcysteine ​​(nac) or metamizole. nac is the accepted antidote for acetaminophen toxicity and is warranted in patients at significant risk of hepatotoxicity. metamizole is an anti-inflammatory and antipyretic drug that is banned in most countries because of the potential for nephrotoxicity.
  • Action
    The action of field code CHC 16-01 & DC 16-02 initiated by Siemens addresses the sending of a Letter to Customer with risk classification III (situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences). Recommendation to users and patients: Venous puncture should be performed prior to the administration of NAC or Metamizole. Baseline values ​​prior to administration of NAC or Metamizole therapy are not affected.

Device

Trade Names: Advia 1650 Chemistry System, registration 10345160453; Advia 1200 Chemistry System, ...

Manufacturer

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