The FDA has posted 5 enforcement recalls of multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents devices since 2025, none of them Class I (most serious). Most recent report: May 13, 2026.
Respiratory/sore throat panel test may result in false negative results and control failures.
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents”). Informational only — verify against the FDA before acting.