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U.S. Department of Health and Human Services

Class 3 Device Recall BD FACSLyric Flow Cytometer (433 optical configurations)with FACSuite Clinical Software v1.1

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 Class 3 Device Recall BD FACSLyric Flow Cytometer (433 optical configurations)with FACSuite Clinical Software v1.1see related information
Date Initiated by FirmJanuary 02, 2019
Date PostedFebruary 01, 2019
Recall Status1 Terminated 3 on May 07, 2021
Recall NumberZ-0792-2019
Recall Event ID 81915
510(K)NumberK170974 
Product Classification Flow cytometric reagents and accessories. - Product Code OYE
ProductBD 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 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     
FEI Number 2916837
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact
408-954-2100
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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.
Quantity in Commerce3 devices
DistributionUS Distribution in MD.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OYE
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