Recall Z-1226-2020— Ortho Clinical Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2019-12-16, terminated 2020-11-12. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2.
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-16
- Terminated
- 2020-11-12
- Firm location
- Raritan, NJ, United States
Product description
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
Reason for recall
Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.