enGen Laboratory Automation System — Class III medical device recall Z-2143-2016
Terminated recall by Ortho-Clinical Diagnostics, reported 2016-07-20, distributed nationwide. If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results f
| Recall number | Z-2143-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2016-05-16 |
| Classified | 2016-07-08 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2018-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 30 units |
| Serial numbers | JIM-341592, JIM334236, JIM334527, JIM334986, JIM336167, JIM336481, JIM336745, JIM336855, JIM336957, JIM338283, JIM338290, JIM340024, JIM340658, JIM340667, JIM340934, JIM341021, JIM341174, JIM341352, JIM341392, JIM341415, JIM341426, JIM341679, JIM341750, JIM341820, JIM341866 and 5 more |
Product
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
Reason for recall
If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?.¿ The difference in terminology exists for US Markets only.
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-2143-2016. 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.