Medical Device Recall: NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Luminex Molecular Diagnostics Inc · September 5, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
613
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0043-2025
Status: ongoing
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