Recall Z-1226-2020 ยท JIX Calibrator, Multi-Analyte Mixture
Ortho Clinical Diagnostics Inc
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
| Date | Dec 16, 2019 |
| Status | Terminated |
| Reason | Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2 |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics (Ortho) 16 December 2019, customer letter (Ref. CL2019-343) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail.Letter states reason for recall , health risk and provided with required actions depending upon whether VITROS Calibrator Kit 32 was available for use. VITROS Calibrator Kit 32 is available for use in the U.S. therefore the required actions in order to process urine samples on VITROS Na+ Slides are to:calibrate. o discontinue using the calibration for urine sodium (only) obtained using an affecte |
| Quantity | 39709 units (12734 US and 26975 OUS) |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.