Z-0006-2015Class III

ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy...

Name: Z-0006-2015 ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy...
Creator: ELITech Clinical Systems SAS
Published: 2014-08-11
License: https://open.fda.gov/license/

VitalScientific / initiated 2014-08-11 / Terminated / root cause: manufacturing process

FDA source

ELITech Clinical Systems SAS began a recall of 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... on 2014-08-11. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0006-2015
Classification: Class III
Status: Terminated
Initiated: 2014-08-11
Posted: 2014-10-02
Terminated: 2014-12-11
Recalling firm: VitalScientific
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.
Product code: CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ELITech sent an Urgent Product Recall Notice letter dated August 12, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To All Users, ***Effective immediately, please discontinue using this product.*** Actions to be taken: "Laboratories must not use this product and must destroy all remaining inventory of the product. "If you have transferred any of this product to another location, please forward a copy of this bulletin to that location. "All users receive ENVOY 500 AST REAGENT KIT, reference 55255, from distributors. To be certain everyone who is possibly affected by this is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached confirmation receipt to Technical Support by fax (401-642-9003) within 48 hours of receipt. On August 20, 2014:, customers were contacted with an interim solution. On September 3, 2014, the firm sent Technical Bulletin 5056 and Distributor Notice D057/Customer Notice C061 to all Envoy users notifying that the recalled Envoy AST Reagent (ref 55255) was being discontinued; the old Envoy AST Reagent (ref. 55250) was being reinstated. On September 23, 2014, the firm sent the URGENT: PRODUCT RECALL NOTICE "UPDATE", dated 19 September 2014, to all Envoy users stating that old (original) Envoy 500 AST Reagent Kit (ref 55250) will replace the recalled Envoy 500 AST Reagent Kit (ref 55255). As confirmation of receipt of this notice, please return the attached confirmation receipt to Technical Support by fax (401-642-9003) within 48 hours of receipt. Customers with questions about this recall, please call the Technical Support at 1-855-354-8324 (1-855-ELITECH).
Quantity in commerce: 878 kits
Distribution: Nationwide Distribution
Product codes and lots: Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0006-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0006-2015	Class III	Terminated	Voluntary: Firm initiated	2014-10-08	2014-10-02

Product code CIT

K102647Class IIElitech Clinical Systems Selectra Prom/elical 2/Elitrol I and Elitrol Ii/ast/got 4+1 Sl/potassium, Sodium, Chloride...Elitechgroup Vital Scientific BV / cleared 2011-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)