FDA Device recall Z-0006-2015
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500
- FDA Device
- Class III
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class III recall of ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500 by Elitech Clinical Systems Sas, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0006-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-08-11 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elitech Clinical Systems Sas |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0006-2015%22
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