FDA-Device2012-08-01Class II
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Ortho-Clinical Diagnostics
Hazard
software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
Sold states
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.
Affected count
77
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2067-2012Don't want to check this manually?
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