BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1… recallZ-0792-2019 · Becton, Dickinson and Company, BD Biosciences · initiated Jan 2, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton, Dickinson and Company, BD Biosciences or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated 12/26/2018; telephoned and emailed its consignee on 01/02/2019. BD Service will install the correction. The letter described the product, problem and actions to be taken. The consignees were instructed to: 1. Retain this letter with the instrument records maintained by your facility. 2. Complete the attached Customer Response Form and return to the contact noted so that BD may acknowledge your receipt of this notification via Email: [email protected] Attn: BD Regulatory Compliance. If you require further assistance, please contact: BD Customer/Technical Support; BD Customer Support at 855.236.2772 (prompt 2) for instruments in the United States. For customers outside the US, contact your local BD representative or distributor.
Recall details
- Recall number
- Z-0792-2019
- Status
- Terminated
- Initiated by the company
- Jan 2, 2019
- Posted by the FDA
- Feb 1, 2019
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 3 devices
- Product code
- OYE
- FDA submissions
- K170974
- Distribution
- US Distribution in MD.
Product description
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.
Code information (models, lots, serial numbers)
UDI: (01)00382906628787(11)180508(21)Z662878000056 serial number: Z662878000056 Work Station SN 2UA80820ZZ UDI: (01)00382906628787(11)180301(21)Z662878000029 serial number: Z662878000029 Work Station SN 2UA80820ZW UDI: (01)00382903389605(11)180315(21)11662382000007 serial number: R662382000007 Work Station SN 2UA8082101
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- FACSCanto 338960Becton, Dickinson And Company · Counter, differential cell1 recall117 reports
- BD FACSLyric 662878Becton, Dickinson And Company · Flow cytometric reagents and accessories.2 recalls23 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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