BioFire Respiratory Panel 2.1 (BioFire) – False Negative Risk (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, IVD, REF: 423742 (30 test kit)
Brand
BioFire Diagnostics, LLC
Lot Codes / Batch Numbers
UDI: 00815381020529 /Lot # 2649724
Products Sold
UDI: 00815381020529 /Lot # 2649724
BioFire Diagnostics, LLC is recalling BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) due to Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Recommended Action
Per FDA guidance
On October 22, 2025, Biomerieux issued a "Urgent: Medical Device Recall" Notification to affected consignees via E-Mail. Biomerieux asked consignees to take the following actions: 1. 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. Please confirm the quantity of kits that have been destroyed, previously used, or returned 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. 6. Complete and submit the report online. Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
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 noticePage updated: Jan 10, 2026