Devices

Device Recall Creatinine

Model / Serial
All
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.
Product Description
Creatinine, Part Numbers OSR6178, OSR6678 || Product Usage: || System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall Creatinine

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Creatinine reagent

Model / Serial
Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
Creatinine Plus ver. 2. || Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Manufacturer
Roche Diagnostics Operations, Inc.

Device Recall Creatinine Plus

Model / Serial
Catalog Numbers: 11775685216; 11875566216; 11875582216.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
Creatinine Plus. || Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Manufacturer
Roche Diagnostics Operations, Inc.

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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.

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