Biofire Spotfire Respiratory/Sore Throat Panel recall
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Why was Biofire Spotfire Respiratory/Sore Throat Panel recalled?
Respiratory/sore throat panel test may result in false negative results and 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?
Lot Number: 2215125/UDI: 00815381020390
- Product
- Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 2400 pouches
- Distribution
- US Nationwide distribution in the states of MS, TX MN, VA.
- Recall date
- May 13, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)