# FDA recall Z-1488-2021

> **Luminex Corporation** · Class II · device recall initiated 2021-03-18.

## Product

VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

## Reason for recall

Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

## Distribution

Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.

## Key facts

- **Recall number:** Z-1488-2021
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-18
- **Report date:** 2021-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northbrook, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2021

## Citation

> AI Analytics. FDA recall Z-1488-2021. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1488-2021. Source: US FDA. Licensed CC0.

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