Class 2 Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325

• Date Initiated by Firm: February 24, 2016
• Date Posted: May 03, 2016
• Recall Status: Terminated on May 26, 2017
• Recall Number: Z-1596-2016
• Recall Event ID: 73585
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712.; VITEK 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. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
• Code Information: Lot/Serial: 485368220 Expiry: 12-JAN-17
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: Jeff Scanlan; 314-731-8526
• Manufacturer Reason for Recall: Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
• FDA Determined Cause: Other
• Action: Biomerieux, Inc. sent an Urgent Notice Product Correction on February 24, 2016, to all affected customers. The recalling firm notified their foreign subsidiary of the Field Safety Corrective Action (FSCA) by email. The local subsidiary in the country impacted has informed users impacted and provided instructions to resolve the issue. Customers were instructed to confirm the Field Safety Corrective Action letter has been distributed and reviewed by all appropriate personnel within their organization. ¿ For the referenced test kit (VITEK¿ 2 ASTP605, Lot 485368220), refrain from reporting Minocycline (MNO) results for any organism until a new lot is implemented in your laboratory.¿ o Please note that a bioART rule can be created to suppress the analysis/reporting of Minocycline (reference VITEK¿ 2 Online Software User Manual). The bioART rule can be disabled upon implementation of a new ASTP605 lot number. Customers were instructed tostore the letter with their bioM¿rieux instrument documentation. ¿ Complete the attached Acknowledgement Form and return it to their local bioM¿rieux representative. For questions regarding this recall call 314-731-8526.
• Quantity in Commerce: 337 Kits of 20 Cards/Kit
• Distribution: Worldwide Distribution to China  Taiwan region; No US/military/government 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.