# FDA recall Z-0500-2024

> **Luminex Corporation** · Class II · device recall initiated 2023-11-07.

## Product

Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

## Reason for recall

Potentially defective utility trays in the reagent kits.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.

## Key facts

- **Recall number:** Z-0500-2024
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-07
- **Report date:** 2023-12-13

- **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-0500-2024

## Citation

> AI Analytics. FDA recall Z-0500-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0500-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*