Z-0006-2015 Class III Terminated
FDA device recall Z-0006-2015 was initiated by ELITech Clinical Systems SAS on August 11, 2014 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated December 11, 2014). Affected quantity: 878 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2014
- Initiation Date
- August 11, 2014
- Termination Date
- December 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 878 kits
Product Description
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 for Recall
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.
Distribution Pattern
Nationwide Distribution
Code Information
Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;