Recall database

Respiratory Virus Panel Nucleic Acid Assay System recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IIOngoingZ-1877-2025

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

BioFire Diagnostics, L…UTJun 4, 2025

Class IIOngoingZ-1576-2025

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Abbott Diagnostics Sca…MEApr 23, 2025

Class IIOngoingZ-1573-2025

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Abbott Diagnostics Sca…MEApr 23, 2025