Devices

Device Recall BioRad Variant II Turbo Link Hemoglobin Testing System

Model / Serial
Catalog No. 270-2716 Lot No. 70291030, expiration date 2/28/2010 Lot No. 70392119, expiration date 3/31/2010 Lot No. 70292119R, expiration date 3/31/2010
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA including states of: OH, MN, SC and VA; and country including: Japan.
Product Description
Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick Guide || Intended use: Measurement of Hemoglobin A1c in human whole blood.
Manufacturer
Bio-Rad Laboratories Inc
1 Event
- Recall of Device Recall BioRad Variant II Turbo Link Hemoglobin Testing System

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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