Events

Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Kovalent do Brasil Ltda.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1671
  • Fecha
    2015-08-28
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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