Devices

Device Recall HDLCholesterol,

Model / Serial
Catalog Numbers: 05401488190; 0439980319; 05168805190; 04399803190, 04878205160.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
HDL-Cholesterol plus gen.3.; and Small Supersized || Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of Device Recall HDLCholesterol,

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

One device with a similar name

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Device Recall HDLCholesterol, no pretreatment

Model / Serial
Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
HDL-Cholesterol gen.3. || For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Manufacturer
Roche Diagnostics Operations, Inc.

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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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