FDA Device recall Z-0254-2018
enGen Track System with TCAutomation Software Version 4.2
- FDA Device
- Class II
- terminated
- Published 2017-12-20
On 2017-12-20 the FDA classified a Class II recall of enGen Track System with TCAutomation Software Version 4.2 by Ortho Clinical Diagnostics, citing 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 rein….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0254-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-26 |
| Published | 2017-12-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | GA, IL, MO, NC, NY |
Product
enGen Track System with TCAutomation Software Version 4.2
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
Identifiers
| code_info | Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0254-2018%22
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