Z-0602-2026 Class II Ongoing
FDA device recall Z-0602-2026 was initiated by BioFire Diagnostics, LLC on October 22, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 97 Kits (2,910 pouches).
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