Class 3 Device Recall ENVOY 500 AST Reagent Kit, reference 55255

• Date Initiated by Firm: August 11, 2014
• Date Posted: October 02, 2014
• Recall Status: Terminated on December 11, 2014
• Recall Number: Z-0006-2015
• Recall Event ID: 69024
• 510(K)Number: K102647
• Product Classification: Nadh oxidation/nad reduction, ast/sgot - Product Code CIT
• 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.
• Code Information: Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015
• Recalling Firm/ Manufacturer: ELITech Clinical Systems SAS; Zone lndustrielle; SEES France
• For Additional Information Contact: Technical Support; 855-354-8324
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CIT and Original Applicant = ELITECHGROUP VITAL SCIENTIFIC BV