Biofire Diagnostics, Llc: Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
BioFire Spotfire Respiratory/Sore Throat Panel Recall BioFire Diagnostics is recalling their Spotfire Respiratory/Sore Throat Panel test because it may produce false negative results and control failures, meaning the test could fail to detect infections or not work properly. The affected test kits (REF: 423485) were distributed nationwide across all U.S. states. This is a Class II recall, indicating a serious problem that could result in incorrect test outcomes.
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Reason
- Respiratory/sore throat panel test may result in false negative results and control failures.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of MS, TX MN, VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/10486dd7-195d-427b-a46e-950144aec209