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 5000
- Recall of Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit

2 devices in the database

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

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

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)

Haemoscope Division of Haemonetics Corp

2 devices in the database

Device Recall TEG 5000

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