FilmArray Pneumonia Panel recall
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Why was FilmArray Pneumonia Panel recalled?
Due to manufacturing issue, panels may result in false negative results.
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?
Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482
- Product
- FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 24 Kits (30 pouches/kit)
- Distribution
- US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
- Recall date
- August 30, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)