Events

Recall Or Safety Alert for "EnGen ™ Laboratory Automation Systems" configured with enGen ™ Select or Custom v3.2.2 and lower with Data Innovations, LLC Instrument Manager ™ v8.06 with Data Innovations, LLC TCA Driver v8.04.0020 and lower

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 Data Innovations, 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
    2014-04-02
  • 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
    Software anomaly in certain configurations of the "EnGen ™ Laboratory Automation Systems", manufactured by Data Innovations, Inc., USA.

Device

"EnGen ™ Laboratory Automation Systems" configured with enGen ™ Select or Custom v3.2.2 and lower...

Manufacturer

Data Innovations, Inc.
  • Source
    AEMPSVFOI