Devices

Device Recall Hemochron JR. Microcoagulation Systems Prothrombin Time (PT).

Model / Serial
Catalogue/Code J201 Lot Number: FOJPT059, GOJPT067, GOJPT068, GOJPT069, GOJPT070, GOJPT072, GOJPT073, GOJPT074, GOJPT075, HOJPT076, HOJPT077, HOJPT078, HOJPT079, HOJPT080, HOJPT081, HOJPT082, HOJPT083, JOJPT084, JOJPT085, JOJPT086, JOJPT087, JOJPT088, JOJPT090, KOJPT091, KOJPT092, KOJPT093, MOJPT094, MOJPT095, MOJPT096, MOJPT097, MOJPT098, MOJPT099, A1JPT001, A1JPT002 A1JPT003 A1JPT005 A1JPT007 A1JPT008, A1JPT009, A1JPT010, A1JPT011, A1JPT012, A1JPT013, A1JPT014, A1JPT015, A1JPT016, A1JPT017, A1JPT018, A1JPT019, A1JPT021, A1JPT023, A1JPT024, A1JPT025, B1JPT032, B1JPT033, C1JPT035, C1JPT038, C1JPT041, and C1JPT045.
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
Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). || International Ethidine Corp (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 Hemochron JR. Microcoagulation Systems Prothrombin Time (PT).

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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