Events

Recall Or Safety Alert for Enzymatic Creatinine Test (ECREA), catalog number K1270A, SMN 10700444, Dimension Vista® 500 SMN 10488224, Dimension Vista® 1000 SMN 10444802

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 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
    2017-03-15
  • 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 falsely elevated Enzymatic Creatinine (ECREA) results in the Dimension Vista® 500 and 1500 Systems, manufactured by Siemens Healthcare Diagnostics Inc., USA, when this test is processed after acid cleaning "Acid Clean (ACLN ) ".

Device

Enzymatic Creatinine Test (ECREA), catalog number K1270A, SMN 10700444, Dimension Vista® 500 SMN ...

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    AEMPSVFOI