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
Check against the official notice below — it lists the full affected range.
Ortho Clinical Diagnostics Inc is recalling VITROS Chemistry Products Calibrator Kit 2, which is used with various VITROS Chemistry Systems and Integrated Systems for laboratory testing. The recall affects 39,709 units (12,734 in the US and 26,975 outside the US) distributed nationwide and internationally to countries including Canada, Australia, Brazil, Chile, China, Colombia, India, Japan, Mexico, Singapore, the United Kingdom, and several European nations. The affected lots are: Lot 277 (expiration 11-Dec-2019), Lot 288 (expiration 31-May-2020), Lot 298 (expiration 12-Nov-2020), and Lot 219 (expiration 15-Jul-2021).
The reason for the recall is a potential for negatively biased sodium (Na+) urine results when using several lots of this calibrator kit. The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
Reason for recall: Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2 Distribution: 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 Quantity: 39709 units (12734 US and 26975 OUS) 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.