Luminex Molecular Diagnostics Inc
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Luminex Molecular Diagnostics Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-16FDA-DeviceClass IINxTAG 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.
- 2024-10-16FDA-DeviceClass IINxTAG 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.
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