Recall Z-0792-2019 ยท OYE Flow Cytometric Reagents And Accessories.
Becton, Dickinson and Company, BD Biosciences
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, ac
| Date | Feb 1, 2019 (initiated Jan 2, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 Cus |
| Quantity | 3 devices |
| Distribution | US Distribution in MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multit Becton, Dickinson and Company, Jul 3, 2017 |