enGen Laboratory Automation System — Class II medical device recall Z-1724-2015
Terminated recall by Ortho-Clinical Diagnostics, reported 2015-06-17, distributed nationwide. Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modul
| Recall number | Z-1724-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2015-05-06 |
| Classified | 2015-06-08 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2018-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, CN, ES, FR, GB, IN, IT, NO, PT, SE |
| Serial numbers | 341516, IM341243, J271265, J271267, J271369, J271372, J30370, J3055507, J3055510, J57662, J7021530, J7023648, J7023841, J7023890, J7024894, J7025007, J75685, J8006290, J85208, J89134, JIM-341592, JIM334236, JIM334527, JIM336167, JIM336855 and 20 more |
Product
enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). COMMON NAME: enGen Track System. The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.
Reason for recall
Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Exit or Rack Exit module. These situations may result in splashing of bio-hazardous fluid. Sample cross-contamination may occur with an uncapped tube in the rack.
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-1724-2015. 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.