BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- October 22, 2025
- Posted
- November 26, 2025
- Recall Number
- Z-0602-2026
- Quantity
- 23 kits (690 pouches)
- Firm Location
- Salt Lake City, UT
Reason for Recall
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Distribution
US Nationwide distribution in the states of ID, OR, AZ.
Lot / Code Info
UDI: 00815381020529 /Lot # 2649724
Root Cause
Under Investigation by firm
Action Taken
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.