Drug recall
enGen Track System with TCAutomation Software Version 4.2
FDA recall event 77172 · Class II · Ortho-Clinical Diagnostics
Key facts
| Event ID | 77172 |
|---|---|
| Recall numbers | Z-0254-2018 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Product type | Devices |
| Products | enGen Track System with TCAutomation Software Version 4.2 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Apr 26, 2017 |
| Report date | Dec 20, 2017 |
| Termination date | Aug 23, 2021 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1000136573 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: