BioFire Respiratory Panel 2.1 plus Kit recall
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Why was BioFire Respiratory Panel 2.1 plus Kit recalled?
Due to manufacturing error, respiratory panel may result in elevated control failures and/or 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?
Lot# 1475424/ UDI: None
- Product
- BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 30 kits
- Distribution
- International distribution in the country of Singapore.
- Recall date
- June 4, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)