Safety Alert for ARCHITECT STAT TROPONINA-I REAGENT KIT .. Registration at Anvisa: 80146501213.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil Ltda.

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    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.
  • Reason
    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.
  • Action
    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.