Z-2936-2026 Class II Ongoing
FDA device recall Z-2936-2026 was initiated by BioFire Diagnostics, LLC on June 24, 2026 and is designated Class II. Reason for recall: Due to increase in false negative results The recall status is ongoing. Affected quantity: 2,370 pouches (79 kits).
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2026
- Initiation Date
- June 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,370 pouches (79 kits)
Product Description
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Reason for Recall
Due to increase in false negative results
Distribution Pattern
U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
Code Information
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125