Recall Z-0042-2025— Luminex Molecular Diagnostics Inc
Class II · Ongoing
Class II FDA medical device recall by Luminex Molecular Diagnostics Inc, initiated 2024-09-05. It names 2 FDA 510(k) clearances: K193167, K152386. Product: NxTAG Respiratory Pathogen Panel, REF: I051C0447. 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..
- Recalling firm
- Luminex Molecular Diagnostics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-05
- Firm location
- Toronto, Canada
510(k) clearances named in this recall
2 on FDA's record- K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- K152386 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NxTAG Respiratory Pathogen Panel, REF: I051C0447
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.