Device product

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.

Z-0006-2015

August 11, 2014

Class III

Product summary

Firm: ELITech Clinical Systems SAS
Event: Event 69024
Status: Terminated
Classification: Class III
Quantity: 878 kits
Official record key: device-enforcement:Z-0006-2015

Official wording

Reason: 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.

Code information: Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;

Distribution pattern: Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.