Devices

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.
Manufacturer
Tcoag Us, Incorporated
1 Event
- Recall of Device Recall Minutex DDimer

Manufacturer

Tcoag Us, Incorporated

Manufacturer Address
Tcoag Us, Incorporated, 330 Waterloo Valley Rd, Budd Lake NJ 07828-1395
Source
USFDA

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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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