Recall Z-2184-2019 ยท JIX Calibrator, Multi-Analyte Mixture
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
| Date | Jul 8, 2019 |
| Status | Terminated |
| Reason | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Root cause | Software design |
| Action | Customers were notified prior to July 10, 2019. For the VITROS 250, 250AT, and 350 chemistry system: Do not use VITROS Calibrator Kit 32 to calibrate assays until an Ortho trained service personnel reconfigures your system(s) with the correct parameters for VITROS Calibrator Kit 32. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification by each system that may use VITROS Calibrator Kit 32 until your system is reconfigured by an Ortho trained representative. Please forward this notification if the product was distributed outside of your fac |
| Quantity | 55 |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM Ortho-Clinical Diagnostics, Inc., Nov 13, 2006 |