Events

Field Safety Notices about ADVIA Immunochemistry Systems, Tip: Centaur; Centaur CP; Centaur XP

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by SIEMENS HEALTHCARE DIAGNOSTICS INC.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Date Posted
    2014-04-12
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/12/04/vazno-obavestenje-o-medicinskom-sredstvu-advia-immunochemistry-systems-tip-centaur-centaur-cp-centaur-xp/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics conducts on-site corrective action for the advia centaur and advia centaur xpimmunoassaysisteme, for fluid reservoir connector hoses. wash 1, acid and base tanks hoses may be affected. siemens has claimed that some systems may cause slight hoses to burst at the junction point of the reservoir connectors or the consequences of mechanical damage. bursting can lead to a low leakage of fluid into the tank or drip tray located inside the tank. there is a possibility for minimal fluid leakage outside the system. the leak will cause the tank to be emptied more quickly than the system expected.

Device

ADVIA Immunochemistry Systems, Tip: Centaur; Centaur CP; Centaur XP
  • Model / Serial
    Bulk FluidReserveAssembly(Acidand Base) -10282187; 10483525, Wash1 Reservoir Connector 10364516; 10483526
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ALIMSA