BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0602-2026
• FDA device classification · QOFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3981The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find BioFire Diagnostics, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.