Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Recalled by Luminex Molecular Diagnostics Due to The Assay may give a false negative result...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Luminex Molecular Diagnostics directly.
Affected Products
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Quantity: 56 Kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: CA, CT, MA, PA
About Luminex Molecular Diagnostics
Luminex Molecular Diagnostics has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report