Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
FDA device recall Z-2081-2026 · posted 2026-05-06 · Open, Classified
Recall details
- Recalling firm
- BioFire Diagnostics, LLC
- Reason for recall
- Respiratory/sore throat panel test may result in false negative results and control failures.
- Action taken
- On April 1, 2026, Biomerieux, issued a "Urgent Medical Device Recall" via E-Mail. Biomerieux ask consignees to take the following actions: In this context, we request that you take the following actions: " Examine your inventory for the lot identified in this recall notice. "Discontinue use and discard any remaining product from this lot in your possession. "Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form. "If you have further distributed this product, please identify any recipients and notify them at once. " Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- QOF
- Quantity affected
- 2400 pouches
- Distribution
- US Nationwide distribution in the states of MS, TX MN, VA.
- Date initiated
- 2026-04-01
- Date posted
- 2026-05-06
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel (K232954) | Biofire Diagnostics, LLC | 2024-03-26 |