Events

Safety Alert for kit AxSYM TROPONIN - I Reagent. Lot: 90172M300

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
    709
  • Date
    2002-10-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Abbott Laboratories is working to speed up product replacement. ///////// NOTE: Are all results between 0.5 and 2.0 ng / mL suspect? - No, only some apparently healthy patients can show results between 0.5 and 2.0 ng / ml. Consider that for the diagnosis in myocardial infarction, an initial result of AxSYM TROPONINE - I Reagent. Lot: 90172M300, should be analyzed in conjunction with other cardiac markers (CK-MB, Myoglobin), ECG, symptoms and signs, etc.
  • Reason
    Possible increase in the frequency of results above 0.5 ng / ml (from 0.6 to 2.5 ng / ml) in apparently healthy patients. these results, initially above 0.5 ng / ml, once retested present results below 0.5 ng / ml. this possibility was not observed in patients with a confirmed diagnosis of acute myocardial infarction.
  • Action
    Discontinue use of AxSYM TROPONIN - I Reagent. Lot: 90172M300.

Device

kit AxSYM TROPONIN - I Reagent. Lot: 90172M300

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA