FilmArra Pneumonia Panel plus recall
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Why was FilmArra Pneumonia Panel plus recalled?
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00815381020314/Lot# 0979424
- Product
- FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 29 kits
- Distribution
- OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
- Recall date
- April 16, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)