Z-0602-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97 Kits (2,910 pouches)
Product Description
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Reason for Recall
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Distribution Pattern
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
Code Information
UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725