BioFire Respiratory Panel 2.1 recall
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Why was BioFire Respiratory Panel 2.1 recalled?
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
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: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
- Product
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 97 Kits (2,910 pouches)
- Distribution
- US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
- Recall date
- December 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)