Luminex recalls NxTAG Respiratory Pathogen Panel with potential false hMPV results in clinical samples. 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 due to a risk of false positive results for human metapneumovirus (hMPV) in clinical samples. This could lead to incorrect infection diagnoses if the panel detects hMPV when it's not actually present. The recall affects specific lot numbers with expiration dates up to December 31, 2024.
The panel may incorrectly report human metapneumovirus (hMPV) when it's not present, especially in samples that test positive for other pathogens. This can lead to false co-infection results, potentially causing unnecessary treatment or delayed care.
Healthcare providers using the NxTAG Respiratory Pathogen Panel for clinical testing are most at risk. Patients receiving inaccurate test results due to false positives may be affected.
Check the product's lot number and expiration date on the label. Affected units have lot numbers starting with IK051C-0181 through IK051C-0197 with expiration dates up to December 31, 2024.
Look for the lot number and expiration date on the panel's label to determine if it's affected.
The panel may report false positive results for human metapneumovirus (hMPV) in clinical samples, especially when other pathogens are detected, leading to incorrect co-infection results.
Check the lot number on the label; affected units have lot numbers starting with IK051C-0181 through IK051C-0197 with expiration dates up to December 31, 2024.
The recall does not include a remedy, so you should check the product label to confirm if it's affected and contact Luminex for further guidance.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0042-2025 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0042-2025 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.
