Events

Alerte De Sécurité sur Uric Acid - Registration 80115310046; Uric Acid WS - Registry 80115310194; Cholesterol CHOD PAP - Registration 80115310040; Cholesterol WS - Registration 80115310195; GLUCOSE GOD PAP - Registration 80115310038; Glucose WS - Registration 80115310204; HDL C Immuno - Registration 80115310052; Triglycerides GPO-PA Registration 80115310039; Triglycerides WS - Registration 80115310207.. 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 Kovalent do Brasil Ltda.

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
    1671
  • Date
    2015-08-28
  • 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
    Kovalent do brasil ltda, producer and owner of the registrations of the products listed (annex 1), was aware that the products that use the reactions called trinder are the following: n-acetylcysteine ​​(nac), acetaminophen ( paracetamol) 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.
  • 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. More information Attachments 1, 2 and 3.

Device

Uric Acid - Registration 80115310046; Uric Acid WS - Registry 80115310194; Cholesterol CHOD PAP -...

Manufacturer

Kovalent do Brasil Ltda