Alerta De Seguridad para ARCHITECT STAT TROPONINA-I REAGENT KIT .. Registration at Anvisa: 80146501213.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios 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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The US FDA has sent a letter of communication to Anvisa informing about a Class 1 recall alert, issued in that country, involving the product ARCHITECT STAT TROPONINA-I REAGENT. The diagnostic test in question is used to quantify Troponin-I protein, which is produced by the human body after a heart attack. The purpose of this test is to obtain indications for cardiac infarction in patients who have suffered from chest pain in a recent period. In communication with Anvisa, Abbott Laboratories do Brasil Ltda reported that the value of Cut Off (parameter used to define whether or not there is a change in the patient's cardiac condition) normally used in Brazil is 0.3ng / mL, higher than 0 , 1ng / mL.
  • Causa
    The analytical sensitivity of 0.01ng / ml of the architect stat troponin-i reagent diagnostic test may not be checked on all batches of the product. in this way, false-negative results can occur with results lower than 0.1ng / ml (functional test sensitivity) for all batches of this diagnostic test.
  • Acción
    According to information provided by the company Abbott Laboratories do Brasil Ltda, the necessary actions for this case by the users are the following: (a) For laboratories or doctors that use a band less than or equal to 0.1 ng / mL as cut -off, samples should be retested and / or serial blood collections negative, over time, should be evaluated before patients are classified as negative for heart attack; (b) Recent negative results less than 0.1 ng / mL should also be reassessed and the physicians who requested the examination request should be notified; (c) Laboratory reports with negative results less than 0.1 ng / mL should contain the observations of attention in the points of the previous items, alerting health professionals that small elevations of Troponin-I may be lost by the ARCHITECT STAT TROPONIN-I assay and that those negative results do not rule out the possibility of low troponin-I elevations; (d) If the health care professional has sent a consignment of ARCHITECT STAT Troponin-I to another laboratory, it shall communicate this information about the diagnostic kit to such laboratory. Abbott Laboratories of Brazil Ltda also informed Anvisa that it has already sent letters of communication reporting the problem to all customers who received the product.