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Luminex Molecular Diagnostics Inc recalls NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Recalled October 16, 2024 · FDA recall Z-0043-2025 · Luminex Molecular Diagnostics
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. · FDA Class II
Units
613
Sold at
U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.
Description
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.
Product
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Manufacturer(s)
Luminex Molecular Diagnostics Inc
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →