Class 2 Device Recall VITEK 2 Antimicrobial Susceptibility Testing (AST)

• Date Initiated by Firm: October 22, 2018
• Create Date: December 17, 2018
• Recall Status: Terminated on November 04, 2019
• Recall Number: Z-0618-2019
• Recall Event ID: 81415
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products:; Catalog # 410028, VITEK 2 AST-ST01; Catalog # 420915, VITEK 2 AST-ST02; Catalog # 421040, VITEK 2 AST-ST03; ; ; The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
• Code Information: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03
• Recalling Firm/ Manufacturer: bioMerieux, Inc.; 100 Rodolphe St; Durham NC 27712-9402
• For Additional Information Contact: 919-620-2000
• Manufacturer Reason for Recall: False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
• FDA Determined Cause: Component change control
• Action: The Firm, Biomerieux, issued a " URGENT Product Correction Notice" to their consignees informing of the matter and providing certain actions for them to take. Each Notice will be accompanied with an Acknowledge Form which is to be returned to bioMerieux.. The consignees were instructed to take the following action at this time: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " Reference your Laboratory Standard Operating Procedures to identify card types and breakpoints used in your facility to determine if your laboratory is impacted by the issue described in this letter. " Reference your Laboratory Standard Operating Procedures to identify if retrospective analysis is required for reported results associated with the referenced limitation. " For systems utilizing EUCAST breakpoints and operating with VITEK¿ 2 Systems Software version 8.01, create a bioART Rule for the referenced limitation associated with Ceftriaxone (cro01n). " Please store this letter with your bioM¿rieux instrument documentation. -Please complete the attached Acknowledgement Form (Attachment A) and return it to bioM¿rieux, Inc. If you have any questions or concerns, please contact your local bioM¿rieux representative or call , Regulatory Quality Compliance Specialist, at 314-731-8805 or email: debra.broyles@biomerieux.com.
• Quantity in Commerce: 184,374
• Distribution: Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY including Puerto Rico and to countries of:Algeria, Angola, Azerbaijan, Bahrain, Bangladesh, Belarus, Sarl, Benin, Bosnia-Herz, Cameroon, Chad, Cote d'Ivoire, Croatia, Dem. Rep. Congo, Egypt, , Georgia, Guam, Ethiopia, Iraq, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, UAB, Lithuania, Macedonia, Malta, Mongolia, Morocco, Mozambique, Niger, Oman, Pakistan, Palestine, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, Sri Lanka, Tunisia, Ukraine, Gabon, and Zimbabwe.
• 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.