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Recall Observatory FDA recall evidence

Device product

NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

Z-0043-2025

September 05, 2024

Class II

Product summary

Firm
Luminex Molecular Diagnostics Inc
Event
Event 95377
Status
Ongoing
Classification
Class II
Quantity
613
Official record key
device-enforcement:Z-0043-2025

Official wording

Reason: 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.

Code information: Lot/Expiration: IK056C-0033/ 9/30/2024, IK056C-0034/ 10/31/2024, IK056C-0035/ 10/31/2024, IK056C-0036/ 12/31/2024, IK056C-0037/ 12/31/2024, IK056C-0038/ 12/31/2024, IK056C-0039/ 1/31/2025

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.