Events

Safety Alert for Centaur Siemens immunoassay unit

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens Healthcare Diagnostics Inc. || Siemens Helathcare Diagnostics Manufacturing Limited || Siemens Healthcare Diagnostics Mfg Ltd || Stratec Biomedical Switzerland Ag.

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
    Safety alert
  • Event ID
    I1604-146
  • Event Number
    2008DM-0002712
  • Date
    2016-04-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=147
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer has detected a problem with the use of the insertion cups / ezee-nest (smn 10313057) due to two errors that exist in the operation guide of the referenced device, due to the volumes of aspiration vs the volumes of the sample, which could lead to there are potentially delays in patient care or loss of samples.

Device

Centaur Siemens immunoassay unit

Manufacturer

Siemens Healthcare Diagnostics Inc. || Siemens Helathcare Diagnostics Manufacturing Limited || Si...
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA