International Medical Devices Database

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here

Type of Event
Recall
Date
2002-04-11
Event Country
France
Event Source
ANSM
Event Source URL
https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-du-produit-dimension-etalon-hdl-direct-ahdl-de-la-societe-dade-behring
Notes / Alerts

French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
DADE BEHRING withdraws from the market lot 1FD010 (per 01.06.02) of the in vitro diagnostic medical device called Dimension / Etalon HDL Direct (AHDL) - reference DC48, following a decrease in stability over time that may lead to inaccurate calibration, invalidated by out-of-specification quality controls. This device is involved in the determination of high density lipoprotein (HDL) cholesterol in serum and plasma on the Dimension clinical chemistry system.

Device

Dimension / Etalon HDL Direct

Model / Serial
Product Description
in-vitro_medical_device
Manufacturer
DADE BEHRING

Manufacturer

DADE BEHRING

Source
LAANSM

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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Recall of Dimension / Etalon HDL Direct

What is this?

Device

Dimension / Etalon HDL Direct

Manufacturer

DADE BEHRING