Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0217-2016 — 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 CHOLESTER

U.S. FDA — Device Enforcement · France · 2015-09-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0217-2016
Date of alert: 2015-09-22
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: ELITech Clinical Systems SAS
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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