Events

Recall Or Safety Alert for Calibrator (MYO CAL) lot 4FD085, catalog number KC624 (smn 10445191) used in the Systems Dimension View Myoglobin

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
    2014-12-02
  • 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 batch 4FD085 of the Myoglobin Calibrator (MYO CAL) used with the systems "Dimension Vista®, manufactured by Siemens Healthcare Diagnostics Inc, USA, due to the possibility of positive bias in the results of patients

Device

Calibrator (MYO CAL) lot 4FD085, catalog number KC624 (smn 10445191) used in the Systems Dimensio...

Manufacturer

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