Luminex recalls xTAG Respiratory Viral Panel (RVP) with catalogue number I019C0111 due to potential false negative results for Influenza A (H3) and RSV A. This may lead to missed diagnoses but does not affect other virus detection.
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.
Luminex is recalling its xTAG Respiratory Viral Panel (RVP) with catalogue number I019C0111 because it can sometimes give false negative results for Influenza A (H3) and RSV A. This means tests might miss infections that could be treated, but the panel still works for other viruses.
The test might show a negative result when the patient actually has Influenza A (H3) or RSV A, leading to missed diagnoses. However, it still correctly identifies other viruses like Influenza B, RSV B, and other respiratory pathogens.
People using the xTAG Respiratory Viral Panel (RVP) for testing respiratory infections. Those most at risk are healthcare providers and labs that rely on this test for Influenza A (H3) and RSV A detection.
Check for the box label 'xTAG RVP (Respiratory Viral Panel)' and catalogue number I019C0111. The product was sold with lot numbers IK019C-0129 through IK019C-0132.
Look for the box label 'xTAG RVP (Respiratory Viral Panel)' and catalogue number I019C0111 on the product packaging.
No, the recall is for potential false negatives, not a physical hazard.
Yes, the test continues to detect Influenza A, Influenza B, RSV B, and all other targets as claimed.
Check the product label and catalogue number to confirm if it's affected. If it is, contact Luminex for guidance.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0161-2020 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0161-2020 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.
