Events

Recall Or Safety Alert for INNOVANCE® DTI test, in the Sysmex® CS-5100 system, catalog number OPOH03 and Siemens material number (SMN) 10873467

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 Siemens Healthcare Diagnostics Products GmbH.

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
    2017-01-30
  • 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
    Cessation of the use of the INNOVANCE® DTI test of the Sysmex® CS-5100 System, manufactured by Siemens Healthcare Diagnostics Products GmbH, Germany, because the ID for the configuration of the application is erroneous, which may cause an invalid calibration curve .

Device

INNOVANCE® DTI test, in the Sysmex® CS-5100 system, catalog number OPOH03 and Siemens material nu...

Manufacturer

Siemens Healthcare Diagnostics Products GmbH
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    AEMPSVFOI