# FDA recall Z-1903-2025

> **Luminex Corporation** · Class II · device recall initiated 2025-04-16.

## Product

VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

## Reason for recall

It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.

## Distribution

US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.

## Key facts

- **Recall number:** Z-1903-2025
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2025-04-16
- **Report date:** 2025-06-11

- **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-1903-2025

## Citation

> AI Analytics. FDA recall Z-1903-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1903-2025. Source: US FDA. Licensed CC0.

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