Recall Z-2081-2026 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
BioFire Diagnostics, LLC
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
| Date | May 6, 2026 (initiated Apr 1, 2026) |
| Status | Open, Classified |
| Reason | Respiratory/sore throat panel test may result in false negative results and control failures. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 2400 pouches |
| Distribution | US Nationwide distribution in the states of MS, TX MN, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Biofire Diagnostics, LLC, Mar 26, 2024 |