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FDAJuly 16, 2019device

xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

luminex molecular diagnosticsluminexluminex molecular

UPCs

00840487100462

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test — Recall Details · AllClear