Devices

Device Recall IL GEM PCL/PCL Plus Gem Test PT Cartridge

Model / Serial
ID #: 6260030000. Lot Numbers: A1ILJPT001, H0ILJPT005, and K0ILJPT006.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.
Product Description
IL GEM PCL/PCL Plus - Gem Test PT Cartridge || ITC-Nexus Dx || A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
Manufacturer
International Technidyne Corp.
1 Event
- Recall of Device Recall IL GEM PCL/PCL Plus Gem Test PT Cartridge

Manufacturer

International Technidyne Corp.

Manufacturer Address
International Technidyne Corp., 68 Olsen Ave, Edison NJ 08820-2419
Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
USFDA

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