Devices

Device Recall directCheck

Model / Serial
Catalog number: DCJLR-N; Lot number: M9DNL055, exp. 9/2010
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and one customer in Belgium.
Product Description
International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic || 15 vials || For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems.
Manufacturer
International Technidyne Corp.
1 Event
- Recall of Device Recall directCheck

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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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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