Devices

Device Recall VITROS Chemistry Products Calibrator Kit 16

Model / Serial
Lot 1630
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Class II Recall: Worldwide Distribution - USA (Nationwide) and the countries of Brazil, Canada, Chile, China, Colombia, England, France, Mexico, Panama, Singapore, Spain, Venezuela.
Product Description
VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS Chemistry Products Calibrator Kit 16

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
Source
USFDA

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