FDA-Device2019-07-10Class II
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Ortho-Clinical Diagnostics
Hazard
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Sold states
US Nationwide Distribution
Affected count
3889 units
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1936-2019Don't want to check this manually?
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