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Luminex Molecular Diagnostics Recalls
4 recalls on record · June 19, 2019 to October 16, 2024 · Medical Devices
Recalls by year
19
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 16, 2024Medical DevicesFDA
Luminex Molecular Diagnostics Inc recalls NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Hazard: 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.
October 16, 2024Medical DevicesFDA
Luminex Molecular Diagnostics Inc recalls NxTAG Respiratory Pathogen Panel, REF: I051C0447
Hazard: 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.
October 30, 2019Medical DevicesFDA
Luminex Molecular Diagnostics recalls xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in v
Hazard: The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.
June 19, 2019Medical DevicesFDA
Luminex Molecular Diagnostics recalls xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple
Hazard: Reports have been received of lower MS2 MFI values when using the panel.