FilmArray Pneumonia Panel recall
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Why was FilmArray Pneumonia Panel recalled?
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621
- Product
- FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 9 kits (U.S. only)
- Distribution
- U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
- Recall date
- June 30, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)