Device 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

Z-1226-2020

December 16, 2019

Class II

Product summary

Firm: Ortho Clinical Diagnostics Inc
Event: Event 84654
Status: Terminated
Classification: Class II
Quantity: 39709 units (12734 US and 26975 OUS)
Official record key: device-enforcement:Z-1226-2020

Official wording

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

Code information: 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

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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