Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Biosys Ltda; DiaSys Diagnostic Systems Gmbh.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1666
  • Date
    2015-08-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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