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

Recalled February 19, 2020 · FDA recall Z-1226-2020 · Ortho Clinical Diagnostics

Hazard

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

Units

39709 units (12734 US and 26975 OUS)

Sold at

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

Description

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

Product

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

Manufacturer(s)

Ortho Clinical Diagnostics Inc

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