# FDA recall Z-0792-2019

> **Becton, Dickinson and Company, BD Biosciences** · Class III · device recall initiated 2019-01-02.

## Product

BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878    BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.

## Reason for recall

A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for research use only.

## Distribution

US Distribution in MD.

## Key facts

- **Recall number:** Z-0792-2019
- **Recalling firm:** Becton, Dickinson and Company, BD Biosciences
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-02
- **Report date:** 2019-02-13
- **Termination date:** 2021-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0792-2019

## Citation

> AI Analytics. FDA recall Z-0792-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0792-2019. Source: US FDA. Licensed CC0.

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