Device product
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Z-0602-2026
Product summary
- Event
- Event 97870
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 97 Kits (2,910 pouches)
- Official record key
device-enforcement:Z-0602-2026
Official wording
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.
Code information: UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
Distribution pattern: US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
Derived failure modes
-
Unknown
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.