# FDA recall Z-1109-2022

> **Luminex Corporation** · Class II · device recall initiated 2022-02-15.

## Product

VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

## Reason for recall

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

## Distribution

US

## Key facts

- **Recall number:** Z-1109-2022
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-15
- **Report date:** 2022-05-25

- **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-1109-2022

## Citation

> AI Analytics. FDA recall Z-1109-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1109-2022. Source: US FDA. Licensed CC0.

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