Recall Z-0602-2026 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
BioFire Diagnostics, LLC
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
| Date | Nov 26, 2025 (initiated Oct 22, 2025) |
| Status | Open, Classified |
| Reason | Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. |
| Root cause | Under Investigation by firm |
| Action | On May 28, 2026, Biomerieux issued a "Urgent: Medical Device Recall" Expansion Notification to affected consignees via E-Mail. Initial notification was sent out on October 22, 2025. 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 produ |
| Quantity | 97 Kits (2,910 pouches) |
| Distribution | US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.