BD FACSLyric 3L 10C with FACSuite Clinical Software v1 — Class III medical device recall Z-0792-2019
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2019-02-13. A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on
| Recall number | Z-0792-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2019-01-02 |
| Classified | 2019-02-01 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2021-05-07 |
| Quantity | 3 devices |
| UPC / GTIN / UDI-DI | 00382903389605, 00382906628787, 11662382000007 |
| Serial numbers | R662382000007, Z662878000029, Z662878000056 |
| Model numbers | 662878BD |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0792-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.