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Luminex Molecular Diagnostics recalls xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in v
Recalled October 30, 2019 · FDA recall Z-0161-2020 · Luminex Molecular Diagnostics
Hazard
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. · FDA Class II
Units
56 Kits
Sold at
US distribution to CA, CT, MA, and PA OUS: None
Description
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.
Product
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Manufacturer(s)
Luminex Molecular Diagnostics
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →