Devices

Device Recall VITROS 4600 Chemistry System Software

Model / Serial
Version 2.0 & Below
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
Product Description
VITROS 4600 Chemistry System Software || For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS 4600 Chemistry System Software

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

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