BioFire Respiratory Panel (BioFire) – Test Result Errors (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Brand
BioFire Diagnostics, LLC
Lot Codes / Batch Numbers
Lot# 1475424/ UDI: None
Products Sold
Lot# 1475424/ UDI: None
BioFire Diagnostics, LLC is recalling BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems due to Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Recommended Action
Per FDA guidance
On April 30, 2025, Biomerieux issued a "Urgent Field Safety Notice" to affected consignees via email. Biomerieux asked consignees to take the following actions: 1. Immediately examine your inventory for the lot identified in this field safety notice. 2. Discontinue use and discard any remaining product from this lot in your possession. 3. As previously confirmed discontinued use of product, please confirm the amount of kits destroyed on the attached Acknowledgement of Receipt Form. 4. If you have further distributed this product, please identify any recipients and notify them at once. 5. Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026