Z-2081-2026 Class II Ongoing
FDA device recall Z-2081-2026 was initiated by BioFire Diagnostics, LLC on April 1, 2026 and is designated Class II. Reason for recall: Respiratory/sore throat panel test may result in false negative results and control failures. The recall status is ongoing. Affected quantity: 2400 pouches.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2026
- Initiation Date
- April 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2400 pouches
Product Description
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Reason for Recall
Respiratory/sore throat panel test may result in false negative results and control failures.
Distribution Pattern
US Nationwide distribution in the states of MS, TX MN, VA.
Code Information
Lot Number: 2215125/UDI: 00815381020390