Events

Recall Or Safety Alert for Blood gas analyzer RAPIDLab 1260, material numbers 10321846, 10491394 and 10339910 and blood gas analyzer RAPIDLab 1265, material numbers 10321852, 10470366, 10491395 and 10335524

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
    2015-06-02
  • 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
    The RAPIDLab 1260 and RAPIDLab 1265 blood gas analyzers, manufactured by Siemens Healthcare Diagnostics, Inc., USA, do not display the D50 glucose sensor and D51 lactate sensor error codes.

Device

Blood gas analyzer RAPIDLab 1260, material numbers 10321846, 10491394 and 10339910 and blood gas ...

Manufacturer

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