# FDA recall Z-1092-2022

> **Luminex Corporation** · Class II · device recall initiated 2022-04-05.

## Product

Verigene Processor SP, Models 10-0000-07/10-0000-07R  a component of the Verigene system

## Reason for recall

Heater  within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

## Distribution

US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None

## Key facts

- **Recall number:** Z-1092-2022
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-05
- **Report date:** 2022-05-25

- **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-1092-2022

## Citation

> AI Analytics. FDA recall Z-1092-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1092-2022. Source: US FDA. Licensed CC0.

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