Envoy 500 system includes the following product reference numbers and… — Class II medical device recall Z-0217-2016
Terminated recall by ELITech Clinical Systems SAS, reported 2015-11-11, distributed nationwide. ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recall
| Recall number | Z-0217-2016 |
|---|---|
| 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 | 13,455 systems |
Product
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT
Reason for recall
ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 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-0217-2016. 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.