Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and…

Recall date

December 16, 2019

Source

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

Recall number

Z-1226-2020

FDA classification

Class II

Brand / firm

Ortho Clinical Diagnostics Inc

Sold / distributed

Nationwide Foreign: Australia Brazil Canada L3R 4G5 Chile China Colombia India Japan Mexico Singapore United Kingdom France Germany Italy Spain Portugal Poland Russia Denmark Norway Sweden Belgium Netherlands

Why it was recalled

Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2

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 Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659