Recall Or Safety Alert for Reactive strips for glucose determination SPOTCHEM II Glucose, SPOTCHEM II PANEL-1 AND SPOTCHEM II PANEL-V

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 ARKRAY Factory, 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
  • Event Country
  • Event Source
  • 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
    It was sent in 2016-113. Cessation of the use and withdrawal from the market of certain batches of SPOTCHEM II Glucose, SPOTCHEM II PANEL-1 and SPOTCHEM II PANEL-V, manufactured by ARKRAY Factory, Inc., Japan, because they could provide a lower reading for the element glucose, when the blood glucose exceeds the upper limit of the measurement range.


  • Manufacturer Parent Company (2017)
  • Source