Class 2 Device Recall VITEK 2 ASTN461 TEST KIT

• Date Initiated by Firm: July 24, 2026
• Date Posted: September 18, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3231-2026
• Recall Event ID: 99749
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
• Code Information: UDI-DI 03573026637712; Lot Number 1333393504
• FEI Number: 1950204
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: bioMerieux Customer Service Center; 800-6822666
• Manufacturer Reason for Recall: The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
• FDA Determined Cause: Packaging process control
• Action: An URGENT FIELD SAFETY NOTICE notification letter was sent to customers beginning 7/24/26. Required actions Dispose of any remaining inventory VITEK 2 AST-N461 TEST KIT (Ref 424811, Lot 1333393504) that were manufactured with Poucher 8 with timestamps from 10:06:00 to 11:11:59, as identified by product labeling. Inspect each pouch in inventory and dispose of cards with "P8" and timestamps between 10:06:00 to 11:11:59 on the label. Alternatively, dispose of all cards from Lot 1333393504 remaining in inventory. In accordance with your facility s policies, you may consider performing a retrospective review of clinically significant resistant results. Among tests previously performed, identify any possible false resistant results that may have occurred, analyze the related risks, and determine appropriate actions, if applicable. Please ensure that this information is communicated to all relevant personnel within your laboratory, retain a copy in your records, and forward this information to all parties that may use this product, including those to whom you may have transferred the product. Please complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMrieux even if you determine that this product correction notice does not impact your facility. As a reminder, please visit the Resource Center to confirm if a reference package insert is associated with a Field Corrective Action or Field Safety Corrective Action. https://resourcecenter.biomerieux.com/ If you require additional assistance or have any questions, please contact your local bioMrieux Customer Service representative.
• Quantity in Commerce: 97680 units
• Distribution: International distribution to the countries of Austria, Germany, Luxembourg.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.