Recall Z-0651-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
| Date | Oct 19, 2018 |
| Status | Terminated |
| Reason | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On October 19, 2018, Ortho Clinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" notices via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers to inform them of the issue and actions to take to prevent occurrence of the anomaly. On November 19, 2018 Ortho Clinical Diagnostics re-issued correction notices to customers pertaining to the 5,1 FS system (CL2018-194_5,1FS). Customers may continue using their VITROS Systems and have been informed that the software issue will be mitigated with the ne |
| Quantity | 1105 |
| Distribution | US Nationwide Distribution |
| 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 |