# FDA recall Z-0477-2021

> **Luminex Corporation** · Class II · device recall initiated 2020-10-13.

## Product

Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R.  Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

## Reason for recall

Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes.  These text fixtures were used to calibrate and verify VERIGENE SP devices.

## Distribution

Worldwide distribution.  US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey

## Key facts

- **Recall number:** Z-0477-2021
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-13
- **Report date:** 2020-12-02
- **Termination date:** 2024-01-22

- **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-0477-2021

## Citation

> AI Analytics. FDA recall Z-0477-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0477-2021. Source: US FDA. Licensed CC0.

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