Class 2 Device Recall BIOFIRE FILMARRAY Pneumonia Panel plus

• Date Initiated by Firm: February 27, 2025
• Date Posted: April 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1518-2025
• Recall Event ID: 96346
• 510(K)Number: K181324 K222601 K243222
• Product Classification: Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System - Product Code QDS
• Product: FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
• Code Information: UDI: 00815381020314/Lot# 0979424
• Recalling Firm/ Manufacturer: BioFire Diagnostics, LLC; 515 S Colorow Dr; Salt Lake City UT 84108-1248
• For Additional Information Contact: Customer Support Department ; 800-736-6354 Ext. 5
• Manufacturer Reason for Recall: Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On February 28, 2025, Biomerieux issued an "Urgent Field Safety Notice" Recall notification to affected consignees via email. The notice described the product, problem and actions to be taken. Biomerieux asked consignees to take the following actions: " Immediately examine your inventory for the lot identified in this field safety notice. " Discontinue use and discard any remaining product from this lot in your possession. bioMrieux will replace the product at no charge in accordance with our standard limited warranty. " Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. " If you have further distributed this product, please identify any recipients and notify them at once. " Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification. If you require additional assistance or have any questions, please contact your local bioMrieux Customer Service representative or call customer service department at 1-800-736-6354.
• Quantity in Commerce: 29 kits
• Distribution: OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
• 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.

• 510(K) Database: 510(K)s with Product Code = QDS; 510(K)s with Product Code = QDS