Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…

Recall date

August 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0079-2019

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413