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

Recall Z-0006-2015 — ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate

U.S. FDA — Device Enforcement · France · 2014-08-11 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0006-2015
Date of alert: 2014-08-11
Country / jurisdiction: France
Risk level: Class III
Risk type: recall
Brand: ELITech Clinical Systems SAS
Product category: device
Product type: Devices

Reported risk: Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.

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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