FDA-Device2018-10-17Class II
VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915
Ortho-Clinical Diagnostics
Hazard
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Sold states
Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
Affected count
U.S.= 66 ex-U.S.= 76
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2019Don't want to check this manually?
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