Devices

Device Recall VITROS (R) Chemistry Products FS Calibrator 1

Model / Serial
Lots 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (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 (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS (R) Chemistry Products FS Calibrator 1

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

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