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.

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Type of Event
Recall
Event ID
1636015
Event Date Posted
2016-07-07
Event Country
Greece
Event Source
NOM
Event Source URL
http://www.eof.gr/web/guest/withdrawalsmedical?p_p_id=62_INSTANCE_Eh5C&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&_62_INSTANCE_Eh5C_struts_action=%2Fjournal_articles%2Fview&_62_INSTANCE_Eh5C_groupId=12225&_62_INSTANCE_Eh5C_articleId=1636015&_62_INSTANCE_Eh5C_version=1.0
Notes / Alerts

Greek data is current through July 2018. All of the data comes from the National Organization for Medicines, 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 Greece.
Extra notes in the data
Action
Batch recall 20031665 of the product HER2 CISH pharmDx Kit

Device

HER2 CISH

Model / Serial
Product Description
Withdrawal of Lot 20031665 of the HER2 CISH Medical Device PharmDx Kit.
Manufacturer
DAKO DENMARK A/S

Manufacturer

DAKO DENMARK A/S

Manufacturer Parent Company (2017)
Agilent Technologies, Inc.
Source
NOM

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 HER2 CISH

What is this?

Device

HER2 CISH

Manufacturer

DAKO DENMARK A/S