# FDA recall Z-0161-2020

> **Luminex Molecular Diagnostics** · Class II · device recall initiated 2019-07-16.

## Product

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

## Reason for recall

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.

## Distribution

US distribution to CA, CT, MA, and PA    OUS: None

## Key facts

- **Recall number:** Z-0161-2020
- **Recalling firm:** Luminex Molecular Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-16
- **Report date:** 2019-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toronto, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0161-2020

## Citation

> AI Analytics. FDA recall Z-0161-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0161-2020. Source: US FDA. Licensed CC0.

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