Events

Safety Alert for Cholesterol FS - Registration 10350840010; Creatinine PAP FS - Registration 10350840205; Glucose GOD FS (Glucose GOD FS) - Registration 10350840018; HDL-C Immuno FS - Registration 10350840066; LDL-C Select - registration 10350840085; NEFA FS - Registration 10350840251; Triglycerides FS - Registration 10350840011; Uric Acid (TBHBA) FS (Uric acid FS) - Registration 10350840020; Uric acid FS TOOS - Registration 10350840199 - LOTS - All lots

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biosys Ltda; DiaSys Diagnostic Systems Gmbh.

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
    1666
  • Date
    2015-08-20
  • 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 company's statement, the interference of the drugs N-acetylcysteine ​​(NAC), acetaminophen (acetaminophen) and metamizole (dipyrone) is related to the occurrence of falsely low test results using the Trinder reaction, when sample collection to perform the tests is performed immediately after the administration of the same.
  • Reason
    Biosys ltda., the holder of the registrations of the above mentioned products, received a communiqué from the international manufacturer, diasys diagnostic systems gmbh, informing that the products that use as a methodology the reactions called trinder, suffer interference due to the following drugs: n-acetylcysteine ​​(nac), acetaminophen (acetaminophen) and metamizole (dipyrone) given in therapeutic doses. trinder's reactions are based on a color reaction in which the hydrogen peroxide (h2o2) is formed and subsequently reacted with amino-antipyrine (a phenol derivative) and peroxidase as the catalyst. peroxidase reactions have been observed to undergo interference to varying degrees by the drugs mentioned. the products cited use the trinder reaction as a methodology. biosys informs that it has not been notified until the moment of occurrence related to this interference in national territory.
  • Action
    The company recommends blood collection before administration of the following drugs: N-acetylcysteine ​​(NAC), acetaminophen (paraceamol) and metamizole (dipyrone), when testing for the following analytes: Cholesterol, Glucose, HDL, Triglycerides and Uric Acid, which use in their methodology Trinder reactions (products and numbers of registries listed - Annex I). The company made the information available on its website. Further information check: Annex II - Notice to the Client and Annex III - Distribution Map

Device

Cholesterol FS - Registration 10350840010; Creatinine PAP FS - Registration 10350840205; Glucose ...

Manufacturer

Biosys Ltda; DiaSys Diagnostic Systems Gmbh
  • Source
    ANVSANVISA