International Medical Devices Database

Manufacturer Address
Tcoag Us, Incorporated, 330 Waterloo Valley Rd, Budd Lake NJ 07828-1395
Source
USFDA
1 Event
- Recall of Device Recall Minutex DDimer

One device in the database

Device Recall Minutex DDimer

Model / Serial
510 K number: K920668 Device listing number: D099358 Lot Numbers: Expiry Date: C040002 10 July 2012 C042002 14 Jan 2012 B218005 05 Jan 2012 B341002 03 May 2012 B144001 30 Sept 2011
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and country of: Canada.
Product Description
Minutex D-Dimer ; Trinity Biotech plc, || Bray, || Co. Wicklow, || Ireland. || Tel: (353) 1 276 9800, || Fax: (353) 1 276 9888, || Web: www.trinitybiotech.com || Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.

About this database

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

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

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.

Download the data

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.

Download all (zipped)

Tcoag Us, Incorporated

One device in the database

Device Recall Minutex DDimer