# FDA recall Z-2451-2021

> **Luminex Corporation** · Class II · device recall initiated 2021-08-03.

## Product

Verigene EP Amplification Reagent Kit Test

## Reason for recall

There is potential for false positive results.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.

## Key facts

- **Recall number:** Z-2451-2021
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-03
- **Report date:** 2021-09-22

- **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-2451-2021

## Citation

> AI Analytics. FDA recall Z-2451-2021. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2451-2021. Source: US FDA. Licensed CC0.

---

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