# FDA recall Z-1767-2019

> **Luminex Molecular Diagnostics** · Class II · device recall initiated 2019-02-22.

## Product

xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool   (GPP) Kit, IVD, REF  I032C0316.

## Reason for recall

Reports have been received of lower MS2 MFI values when using the panel.

## Distribution

Distribution from the firm's Austin, Texas, location was made to AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, and WI.  There was military distribution but no government distribution.

## Key facts

- **Recall number:** Z-1767-2019
- **Recalling firm:** Luminex Molecular Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-02-22
- **Report date:** 2019-06-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1767-2019

## Citation

> AI Analytics. FDA recall Z-1767-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1767-2019. Source: US FDA. Licensed CC0.

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