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
Safety alert / Field Safety Notice
Event ID
MDA/2013/040
Event Number
CON286865
Date
2013-06-17
Event Date Posted
2013-06-17
Event Country
United Kingdom
Event Source
MHRA
Event Source URL
https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286865?tabName=allTabs
Notes / Alerts

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
Extra notes in the data
Reason
An increase in sensitivity may lead to false positive results in tests for the diagnosis of lupus. this issue may be related to the strip coating. orgentec has sent a recall letter.
Action
Do not use and discard any remaining strips from the affected lots. Consider the need to retest positive results obtained from the affected lots. Contact Launch Diagnostics (01474 876 402) to request replacement strips for re-testing. Clinical pathologists. Biomedical scientists.

Device

Orgentec Alegria dsDNA IgG (ORG204G) for the diagnosis of lupus

Model / Serial
Product Description
Laboratory test kit. Orgentec Alegria dsDNA IgG (ORG204G) for the diagnosis of lupus. Lot numbers: 204G30204 and 204G30205.
Manufacturer
Orgentec Diagnostika GmbH

Manufacturer

Orgentec Diagnostika GmbH

Manufacturer Parent Company (2017)
Wshp Luxco 3 Sarl
Source
MHRA

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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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Safety Alert Or Field Safety Notices for Orgentec Alegria dsDNA IgG (ORG204G) for the diagnosis of lupus

What is this?

Device

Orgentec Alegria dsDNA IgG (ORG204G) for the diagnosis of lupus

Manufacturer

Orgentec Diagnostika GmbH