Devices

Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit

Model / Serial
part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
Product Description
TEG Hemostasis System Level II Control: || Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series || Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System
Manufacturer
Haemoscope Division of Haemonetics Corp
1 Event
- Recall of Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit

Manufacturer

Haemoscope Division of Haemonetics Corp

Manufacturer Address
Haemoscope Division of Haemonetics Corp, 6231 W Howard St, Niles IL 60714-3403
Manufacturer Parent Company (2017)
Haemonetics Corporation
Source
USFDA

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