Class 2 Device Recall VITEK 2 GP ID Test card

• Date Initiated by Firm: August 25, 2017
• Create Date: September 18, 2017
• Recall Status: Terminated on November 09, 2020
• Recall Number: Z-3134-2017
• Recall Event ID: 77935
• 510(K)Number: K952095
• Product Classification: Gram positive identification panel - Product Code LQL
• Product: VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
• Code Information: Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018
• FEI Number: 1950204
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: 314-731-8526
• Manufacturer Reason for Recall: Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC 700327(TM) strain is positive.
• FDA Determined Cause: Under Investigation by firm
• Action: bioMerieux sent an Urgent Product Removval Notice to all affected consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on August 25, 2017. . The directions to the user are as follows: "Please implement the following actions at this time: We request you take the following action at this time: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " Please refrain from using the referenced test kits (VITEK 2 GP ID, Lots 2420240403 and 2420303403) in your laboratory. Destroy any of this product in your inventory, and contact your local bioMrieux representative for credit or replacement. " Please store this letter with your bioMrieux system documentation. " Complete the attached Acknowledgement Form and return it to your local bioMrieux representative." Consignees with questions were instructed to contact their local representative.
• Quantity in Commerce: 11,703 cartons
• Distribution: US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany, Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia, Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Swaziland, Switzerland, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom
• 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 = LQL