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.
- Recall Initiated
- January 2, 2019
- Posted
- February 1, 2019
- Terminated
- May 7, 2021
- Recall Number
- Z-0792-2019
- Quantity
- 3 devices
- Firm Location
- San Jose, CA
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.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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: BDBRC@bd.com 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.