# FDA recall Z-2533-2024

> **Luminex Corporation** · Class II · device recall initiated 2024-06-20.

## Product

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

## Reason for recall

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

## Distribution

US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.

## Key facts

- **Recall number:** Z-2533-2024
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-20
- **Report date:** 2024-08-14

- **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-2533-2024

## Citation

> AI Analytics. FDA recall Z-2533-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2533-2024. Source: US FDA. Licensed CC0.

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