Recall of ENVOY 500 AST Reagent Kits Due to Quality Control Failures
ELITech Clinical Systems is recalling 878 ENVOY 500 AST Reagent Kits because quality control tests are failing before the products expire.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a functional defect (QC failure) rather than a direct safety hazard like contamination or injury.
Plain-English summary
ELITech Clinical Systems SAS is recalling 878 units of the ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for use with Envoy 500 Chemistry Systems. The affected lots are 4014 (expiration 07/2015), 4051 (expiration 09/2015), and 4074 (expiration 11/2015). These kits were distributed nationwide.
The recall was initiated because users have reported that Quality Control (QC) tests are failing before the product reaches its expiration date. The ENVOY 500 AST Reagent is intended for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma, which is used in the diagnosis and treatment of certain liver and heart diseases.
Users of these products should stop using the affected kits and contact ELITech Clinical Systems SAS for further instructions or a replacement.
The recalled product
- 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
- Manufacturer
- ELITech Clinical Systems SAS
- Hazard
- Affected units
- 878
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot 4014
- Expiration date 07/2015
- Lot 4051
- Expiration date 09/2015
- Lot 4074
- Expiration date 11/2015
Distribution
Distributed nationwide across the United States.
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