Recall Z-0043-2025— Luminex Molecular Diagnostics Inc
Class II · Ongoing
Class II FDA medical device recall by Luminex Molecular Diagnostics Inc, initiated 2024-09-05. FDA's recall record names no specific 510(k) clearance for this event. Product: NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468. 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
Product description
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
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.