Ortho-Clinical Diagnostics recalls VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively meas…

Recall date

June 17, 2019

Source

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

Recall number

Z-2202-2019

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN

Why it was recalled

Potentially Biased Results using VITROS Chemistry Products GLU Slides

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 Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems