enGen Track System with enGen Custom v3 — Class II medical device recall Z-0942-2014
Terminated recall by Ortho-Clinical Diagnostics, reported 2014-02-19, distributed nationwide. Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 &
| Recall number | Z-0942-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2013-10-08 |
| Classified | 2014-02-08 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2017-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, ES, GB, IN, IT, PT, SE |
| Quantity | 20 units |
Product
enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
Reason for recall
Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0942-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.