Devices

Device Recall VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5

Model / Serial
All units of these models.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom.
Product Description
VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. || Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A1c in EDTA human whole blood.
Manufacturer
Bio-Rad Laboratories Inc
1 Event
- Recall of Device Recall VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5

Manufacturer

Bio-Rad Laboratories Inc

Manufacturer Address
Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
Source
USFDA

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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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