# FDA recall Z-2011-2021

> **Luminex Corporation** · Class II · device recall initiated 2020-10-30.

## Product

Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

## Reason for recall

Potential for a false-negative result.

## Distribution

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

## Key facts

- **Recall number:** Z-2011-2021
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-10-30
- **Report date:** 2021-07-14

- **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-2011-2021

## Citation

> AI Analytics. FDA recall Z-2011-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2011-2021. Source: US FDA. Licensed CC0.

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