FDA-Device2024-10-16Class II
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Luminex Molecular Diagnostics Inc
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.
Sold states
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.
Affected count
613
Manufactured in
439 University Ave Suite 900, Toronto, Canada
Products
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0043-2025Don't want to check this manually?
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