BioFire Diagnostics, LLC recalls FilmArra Pneumonia Panel plus (Pneumoplus)

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1518-2025
• FDA 510(k) clearance · K181324The device's official FDA premarket clearance record
• FDA 510(k) clearance · K222601The device's official FDA premarket clearance record
• FDA 510(k) clearance · K243222The device's official FDA premarket clearance record
• FDA device classification · QDSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.4001The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find BioFire Diagnostics, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.