Events

Recall Or Safety Alert for Test "Acetaminophen L3K®", references 506-10 / 30

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 Sekisui Diagnostics, P.E.I. Inc.

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
    2016-02-12
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • 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
    Possibility of formation of crystals in reagent R2 and / or deviations from the value of the controls, when using certain batches of the "Acetaminophen L3K®" test, references 506-10 / 30, manufactured by Sekisui Diagnostics, PEI Inc, Canada, when they leave stored in the analyzer.

Device

Test "Acetaminophen L3K®", references 506-10 / 30

Manufacturer

Sekisui Diagnostics, P.E.I. Inc