Devices

Device Recall VITROS Chemistry Products Na Slides

Model / Serial
Generation (GEN): 1 through 6, 30 through 40, 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Product Description
VITROS Na+ Slides, (UPN 10758750004812) || For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS Chemistry Products Na Slides

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 513 Technology Blvd, Rochester NY 14626-3601
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

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