FilmArra Pneumonia Panel plus (Pneumoplus), REF:… recallZ-1518-2025 · BioFire Diagnostics, LLC · initiated Feb 27, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1518-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 27, 2025
- Posted by the FDA
- Apr 4, 2025
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 29 kits
- Product code
- QDS
- FDA submissions
- K181324, K222601, K243222
- Distribution
- OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Product description
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Code information (models, lots, serial numbers)
UDI: 00815381020314/Lot# 0979424
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FilmArray® Pneumonia Panel plus (Pneumoplus) RFIT-ASY-0143Biofire Diagnostics, LLC · Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System3 recalls3 deaths4 reports
Other devices under the same FDA submission
2 devices cleared under K181324, K222601, K243222 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0144Biofire Diagnostics, LLC · Respiratory Panel5 recalls7 reports
- FilmArray® Pneumonia Panel (Pneumo) RFIT-ASY-0145Biofire Diagnostics, LLC · Respiratory Panel2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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