BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Recall
- Recall Number
- Z-0602-2026
- Event Number
- 97870
- Firm
- BioFire Diagnostics, LLC
- FEI Number
- 3002773840
- Product Code
- QOF
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 22, 2025
- Posted
- November 26, 2025
- Address
- 515 S Colorow Dr, Salt Lake City, UT, 84108-1248
Description
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
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.
US Nationwide distribution in the states of ID, OR, AZ.
23 kits (690 pouches)