Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1 Recalled by Becton, Dickinson and Company, BD Biosciences Due to A customer site was identified to have three...

Date: January 2, 2019
Company: Becton, Dickinson and Company, BD Biosciences
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Becton, Dickinson and Company, BD Biosciences directly.

Affected Products

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.

Quantity: 3 devices

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 1 state: MD

Affected (1 state)Not affected

About Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences has 35 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report