BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flo

FDA device recall Z-0792-2019 · posted 2019-02-01 · Terminated

Recall details

Recalling firm: Becton, Dickinson and Company, BD Biosciences
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.
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.
Root cause: Under Investigation by firm
Status: Terminated
Product code: OYE
Quantity affected: 3 devices
Distribution: US Distribution in MD.
Date initiated: 2019-01-02
Date posted: 2019-02-01
Date terminated: 2021-05-07
Location: San Jose, CA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK (K170974)	Becton, Dickinson and Company	2017-07-03