Events

Recall Or Safety Alert for Analyzers are immunological: analyzers of the Advia Centaur series, models: Advia Centaur XP

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Siemens Healthcare Diagnostics, Inc., UNITED STATES OF AMERICA.

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
  • Event Number
    ИМ-7.97890
  • Date
    2014-04-02
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics carries out corrective actions for the advia centaur xp analyzer and reports the following. when the analyzer's cover is lifted, the cover is supported by a gas spring (smn 10321635) attached to the middle of the cover. over time, the gas spring may lose its effectiveness and not keep the cover in full or partially open position. this may cause the cover to fall during equipment maintenance. thus, the cover can cause injury to the operator if dropped. this fact does not affect the results of research.

Device

Analyzers are immunological: analyzers of the Advia Centaur series, models: Advia Centaur XP

Manufacturer

Siemens Healthcare Diagnostics, Inc., UNITED STATES OF AMERICA