Luminex Molecular Diagnostics Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468Class IISep 5, 2024Respiratory pathogen panel may report an elevated rate (7.6	Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-spec	Class IIDevices	Sep 5, 2024
NxTAG Respiratory Pathogen Panel, REF: I051C0447Class IISep 5, 2024Respiratory pathogen panel may report an elevated rate (7.6	Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-spec	Class IIDevices	Sep 5, 2024