International Medical Devices Database

Manufacturer Address
Haemoscope Division of Haemonetics Corp, 6231 W Howard St, Niles IL 60714-3403
Manufacturer Parent Company (2017)
Haemonetics Corporation
Source
USFDA
2 Events
- Recall of Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit
- Recall of Device Recall TEG 5000

2 devices in the database

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

Device Recall TEG 5000

Model / Serial
list 07-022 (TEG 5000), all serial numbers
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA
Product Description
TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 || a multipurpose system for in vitro coagulation studies

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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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Haemoscope Division of Haemonetics Corp

2 devices in the database

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

Device Recall TEG 5000