Recall Z-1877-2025 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
BioFire Diagnostics, LLC
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
| Date | May 29, 2025 (initiated Apr 30, 2025) |
| Status | Open, Classified |
| Reason | Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. |
| Root cause | Under Investigation by firm |
| Action | On April 30, 2025, Biomerieux issued a "Urgent Field Safety Notice" to affected consignees via email. Biomerieux asked consignees to take the following actions: 1. Immediately 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. As previously confirmed discontinued use of product, please confirm the amount of kits destroyed 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. Pl |
| Quantity | 30 kits |
| Distribution | International distribution in the country of Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.