# FDA recall Z-2292-2019

> **Luminex Corporation** · Class II · device recall initiated 2018-06-29.

## Product

Luminex Aries M1 System  Model: Aries M6V1  Aries Software v1.0     For In Vitro Diagnostic Use in clinical laboratories.      Scanner Label/Labeling:  JADAK  JDK-2330 REV B 170512-017

## Reason for recall

An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.

## Distribution

Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom

## Key facts

- **Recall number:** Z-2292-2019
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-29
- **Report date:** 2019-08-28
- **Termination date:** 2021-04-28

- **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-2292-2019

## Citation

> AI Analytics. FDA recall Z-2292-2019. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2292-2019. Source: US FDA. Licensed CC0.

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