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-0080-2019

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