Eon 100 system included the following product reference numbers and… — Class II medical device recall Z-0214-2016
Terminated recall by ELITech Clinical Systems SAS, reported 2015-11-11, distributed nationwide. ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled
| Recall number | Z-0214-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ELITech Clinical Systems SAS, SEES, N/A, France |
| Recall initiated | 2015-09-22 |
| Classified | 2015-11-04 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,389 systems |
| Lot numbers | 100 |
Product
Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL)
Reason for recall
ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.
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-0214-2016. 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.