Luminex recalls NxTAG Respiratory Pathogen Panel +SARS-CoV-2 due to potential false positive results for human metapneumovirus (hMPV). Affected units have specific lot numbers and expiration dates.
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.
Luminex is recalling its NxTAG Respiratory Pathogen Panel +SARS-CoV-2 test kits because they may incorrectly report hMPV infections when there's no actual infection. This false positive can lead to unnecessary treatment or confusion in clinical settings.
The test may show a higher rate of non-specific human metapneumovirus (hMPV) results when other pathogens are present. This can cause false positive co-infection reports, leading to incorrect clinical decisions.
Healthcare providers using the NxTAG Respiratory Pathogen Panel +SARS-CoV-2 test kits are most at risk. Patients receiving false positive results may be unnecessarily treated for hMPV.
Check the lot numbers on the test kit: IK056C-0033 through IK056C-0039. The expiration dates range from September 30, 2024, to January 31, 2025.
Look for lot numbers IK056C-0033 through IK056C-0039 on the test kit.
The test may report false positive results for human metapneumovirus (hMPV) when other pathogens are present, leading to incorrect co-infection reports.
Check the lot numbers on the test kit. If it matches IK056C-0033 through IK056C-0039, it is affected.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0043-2025 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0043-2025 from Luminex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
