Ortho VITROS Chemistry Calibrator Kit 2 Recalled for Potential Sodium Bias
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 units due to a potential for negatively biased sodium (Na+) urine results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of inaccurate diagnostic results (negatively biased Na+ urine results) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling specific lots of the VITROS Chemistry Products Calibrator Kit 2, an in vitro diagnostic (IVD) calibrator used with VITROS Chemistry Systems and Integrated Systems. The recall involves 39,709 units distributed nationwide and in multiple foreign countries, including Australia, Brazil, Canada, and various European nations.
The recall is issued because of a potential for negatively biased sodium (Na+) urine results. The affected product codes and lot numbers include Lot 277 (Exp. 11-Dec-2019), Lot 288 (Exp. 31-May-2020), Lot 298 (Exp. 12-Nov-2020), and Lot 219 (Exp. 15-Jul-2021). The UDI for the product is 10758750009503.
This recall is classified as Class II by the FDA. Users of these calibrators should contact Ortho Clinical Diagnostics for further instructions on how to proceed with the affected units.
The recalled product
- 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
- Ortho Clinical Diagnostics Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ortho Clinical Diagnostics Inc
See all →- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateLactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- HighVITROS CHE slides can cause quality control drift with performance verifiers
FDA (Devices) · 2025-07-23
- HighVITROS CHE slides sold in Japan can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06