International Medical Devices Database

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
Date
2015-07-06
Event Country
Slovenia
Event Source
AMPMDRS
Notes / Alerts

Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Extra notes in the data
Reason
N-acetylcysteine (nac), acetaminophen and metamizole administered in therapeutic concentrations, will cause interferences in so-called trinder reactions. trinder reactions are based on a color reaction in which hydrogen peroxide (h2o2) is formed and subsequently reacts with amino-antipyrine, a phenol derivative and peroxidase as catalyst. peroxidase reactions are disturbed to different extents by above mentioned medications.

Device

Cholesterol FS 5 and others

Model / Serial
Cholesterol FS 5 ‘ version 1 1350 .. 10 ‘ version 1 1300 .. Creatinine PAP FS 1 1759 .. Glucose GOD FS 5 ‘ version 1 2550 .. 10 ‘ version 1 2500 .. Glucose/Hemoglobin IS 1 2491 99 10 760 HDL-C Immuno FS 1 3521 .. LDL-C Select FS 1 4121 .. NEFA FS 1 5781 .. Phospholipids FS 1 5741 .. Triglycerides FS 5 ‘ version 1 5760 .. 10 ‘ version 1 5710 .. Uric acid FS TBHBA 1 3021.. Uric acid FS TOOS 1 3001 ..
Manufacturer
DiaSys Diagnostic Systems GmbH

Manufacturer

DiaSys Diagnostic Systems GmbH

Manufacturer Parent Company (2017)
Gorka Holding - Gmbh
Source
AMPMDRS

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Field Safety Notices about Cholesterol FS 5 and others

What is this?

Device

Cholesterol FS 5 and others

Manufacturer

DiaSys Diagnostic Systems GmbH