medical Class II Updated 2020-02-19

Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Calibrator Kit 2- IVD calibrator

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # /Exp. Date: Lot 277 11-Dec-2019; Lot 288 31-May-2020; Lot 298 12-Nov-2020; Lot 219 15-Jul-2021. UDI: 10758750009503
View official government recall

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