Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
ENVOY 500 AST Reagent Kit Recalled by ELITech Clinical Systems SAS Due to Some users of ENVOY 500 AST Reagent Kit,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ELITech Clinical Systems SAS directly.
Affected Products
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 aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Quantity: 878 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ELITech Clinical Systems SAS
ELITech Clinical Systems SAS has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report