Events

Field Safety Notices about ADVIA Centaur Enhanced Estradiol; , Dimension Vista LOCI Estradiol; , IMMULITE/IMMULITE 1000 Estradiol; , IMMULITE 2000 Estradiol

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Siemens Healthcare Diagnostics Inc., USA.

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 ID
372
Date
2016-01-19
Event Country
Czechia
Event Source
MHSIDCCCDMIS
Event Source URL
https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
Notes / Alerts

Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
Extra notes in the data

Device

ADVIA Centaur Enhanced Estradiol; , Dimension Vista LOCI Estradiol; , IMMULITE/IMMULITE 1000 Estr...

Model / Serial
Catalog Number: ADVIA Centaur® Enhanced Estradiol: 10490889,10491445, 10697757 Dimension Vista® LOCI Estradiol: K6463 IMMULITE®/ IMMULITE 1000 Estradiol: LKE21, LKE21(D) IMMULITE® 2000 Estradiol: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)
Product Description
Diagnostic medical devices in vitro
Manufacturer
Siemens Healthcare Diagnostics Inc., USA

Manufacturer

Siemens Healthcare Diagnostics Inc., USA

Manufacturer Parent Company (2017)
Siemens Ag
Source
MHSIDCCCDMIS

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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