Class II — Potential Health Hazard

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...

Date: July 16, 2019
Company: Luminex Molecular Diagnostics
Status: Ongoing
Source: FDA (Device)

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

Affected (4 states)Not affected

About Luminex Molecular Diagnostics

Luminex Molecular Diagnostics has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report