Recall Or Safety Alert for Kit therascreenKRASPyro (24) 971460, kit therascreenBRAFPyro (24) 971470, kit therascreenEGFRPyro (24) 971480, kit therascreenGISTRapidScreenPyro 971510, kit therascreenNRASPyro (24) 971530, kit therascreenRASExtPyro 971590, reagents PyroMarkGoldQ24 971802

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by N/A.

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
    Recall / Safety Alert
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 recall data from the U.S. and Spain.
  • Extra notes in the data
  • Action
    Cessation of the use of certain batches of the product and review of the results obtained with them, due to the possibility of obtaining altered indices in the peak patterns of the pyrogram, which has been associated with a high rate of invalidations and repetitions of analysis , and with an increased risk of obtaining false positive results with the therascreen RAS Extension Pyro kit.


  • Source