Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative

Recalled October 17, 2018 · FDA recall Z-0080-2019 · 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. · FDA Class II

Units

U.S.= 66 ex-U.S.= 76

Sold at

Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain

Description

Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

Product

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

Manufacturer(s)

Ortho-Clinical Diagnostics

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →