Official recall record
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-09-05
- Country of alert
- Canada
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Luminex Molecular Diagnostics Inc
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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