enGen Laboratory Automation System — Class II medical device recall Z-0300-2017
Terminated recall by Ortho-Clinical Diagnostics, reported 2016-11-02, distributed nationwide. Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to
| Recall number | Z-0300-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2016-09-07 |
| Classified | 2016-10-22 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2018-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BM, CA, CL, DK, FR, GB, IT, MX, NO, PT, SE, TW |
| Reason classes | potency |
| Serial numbers | 17QP94J, 18BFB5J, 1K5K84J, 1LSSF5J, 2S5OP0J, 2Z3YV1J, 37QP34J, 38769917923, 3RHC23J, 46XQH4J, 4DRJ44J, 4HX7S4J, 4SHPF4J, 54FC01J, 5GV6W2J, 5J4B45J, 736BM4J, 7KSC15J, 7YCF43J, 86T205J, 8W7WG3J, 953209, 953221, 953266, 953270 and 34 more |
Product
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System with enGen 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 confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.
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-0300-2017. 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.