# FDA recall Z-0822-2019

> **Luminex Corporation** · Class III · device recall initiated 2018-12-26.

## Product

Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018    The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.

## Reason for recall

On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.

## Key facts

- **Recall number:** Z-0822-2019
- **Recalling firm:** Luminex Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-26
- **Report date:** 2019-02-20
- **Termination date:** 2020-08-04

- **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-0822-2019

## Citation

> AI Analytics. FDA recall Z-0822-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0822-2019. Source: US FDA. Licensed CC0.

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