CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report
Envoy 500 system includes the following product reference recalled
ELITech Clinical Systems SAS is recalling Envoy 500 system includes the following product reference numbers and names: 55345 Envoy, distributed nationwide in the US. The recall was initiated on 22 Sep 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0217-2016
- FDA event ID
- 72322
- Recalling firm
- ELITech Clinical Systems SAS, SEES, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2015
- FDA classified
- 4 Nov 2015
- Reported
- 11 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 22 Sep 2015 | Recall initiated by company | |
| 4 Nov 2015 | Classified by FDA | +43 days |
| 11 Nov 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Envoy 500 system includes the following product reference numbers and names: 55345 Envoy recalled?
Yes. ELITech Clinical Systems SAS recalled Envoy 500 system includes the following product reference numbers and names: 55345 Envoy on 22 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0217-2016.
Why was it recalled?
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.
Which lots are affected?
all lots
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ELITech Clinical Systems SAS
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|---|---|---|---|---|---|
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