Devices

Device Recall VITROS 5600 Chemistry System

Model / Serial
Software Version 3.2 and below; Serial Numbers J56000024 - 56002339
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
Product Description
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS 5600 Chemistry System

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

One device with a similar name

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Device Recall VITROS 5600 Chemistry System

Model / Serial
Software Version 3.2 and below; Serial Numbers J56000024 - J56002309
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.
Product Description
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Manufacturer
Ortho-Clinical Diagnostics

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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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