# FDA recall Z-0445-2019

> **Luminex Corporation** · Class II · device recall initiated 2018-09-14.

## Product

VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits  (packaged as five-pack carriers)     Product Usage:  In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.

## Reason for recall

Potential to lead to a false negative results.

## Distribution

Worldwide Distribution - US Nationwide in the states of United States -  AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR,  PA, SC, TN, TX, UT, VT, WA, KS,  and VA..    France

## Key facts

- **Recall number:** Z-0445-2019
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-14
- **Report date:** 2018-11-21
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0445-2019

## Citation

> AI Analytics. FDA recall Z-0445-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0445-2019. Source: US FDA. Licensed CC0.

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