Luminex Molecular Diagnostics recalls xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro…
- Recall date
- July 16, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0161-2020
- FDA classification
- Class II
- Brand / firm
- Luminex Molecular Diagnostics
- Sold / distributed
- US distribution to CA, CT, MA, and PA OUS: None
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
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