Luminex Molecular Diagnostics Inc Recalls

2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (2)

September 5, 2024
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
Class II
September 5, 2024
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
Class II

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