Devices

Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System

Model / Serial
Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618.
Device Class
Not Classified
Implanted device?
No
Distribution
Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.
Product Description
Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. || The system is intended to be used only with test cuvettes that are available from ITC.
Manufacturer
International Technidyne Corp.
1 Event
- Recall of Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System

Manufacturer

International Technidyne Corp.

Manufacturer Address
International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
Manufacturer Parent Company (2017)
Werfenlife Sa.
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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