# FDA recall Z-1335-2022

> **Luminex Corporation** · Class II · device recall initiated 2022-06-17.

## Product

VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

## Reason for recall

There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

## Distribution

Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

## Key facts

- **Recall number:** Z-1335-2022
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-17
- **Report date:** 2022-07-13

- **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-1335-2022

## Citation

> AI Analytics. FDA recall Z-1335-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1335-2022. Source: US FDA. Licensed CC0.

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