FDAFDA · Food and drugs·Recall number 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 aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Published October 8, 2014 · Recall initiated: August 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ELITech Clinical Systems SAS
- Distributor
- Nationwide Distribution
- Lot
- Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- France
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