Recall Z-0254-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
enGen Track System with TCAutomation Software Version 4.2
| Date | Apr 26, 2017 |
| Status | Terminated |
| Reason | A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track |
| Root cause | Software design (manufacturing process) |
| Action | On 26 April 2017, Ortho Clinical Diagnostic issued a notice titled "Important Product Correction Notification" and a response form (Ref. CL2017-090) to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all potentially affected enGen customers to inform them of the issue and provide them instructions on how to monitor and correct the issue if it has occurred. Foreign affiliates were informed by email on 26 April 2017 of the issue. Potentially affected customers are those that have enGen Systems with: |
| Quantity | 16 |
| Distribution | Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain |
| 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 |