Class 2 Device Recall BD FACSLyric

• Date Initiated by Firm: November 01, 2024
• Date Posted: December 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0747-2025
• Recall Event ID: 95729
• 510(K)Number: K170974 K201814
• Product Classification: Flow cytometric reagents and accessories. - Product Code OYE
• Product: FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket
• Code Information: Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 662877 UDI-DI code: 00382906628770 Instrument Serial Numbers / Power Supply Serial Numbers: Z662877000064 V23180197 Z662877000053 V23090166 Z662877000052 V23090305 Z662877000054 V23090341 Z662877000051 V23090060 Z662877000056 V23090037 Z662877000058 V23090446 Z662877000055 V23090190 Z662877000061 V23180242 Z662877000057 V23090456 Z662877000060 V23180454 Z662877000065 V23180453 Z662877000062 V23300158 Z662877000063 V23300110 Z662877000059 V23180441 Z662877000068 V23300012
• Recalling Firm/ Manufacturer: Becton, Dickinson and Company, BD Bio Sciences; 155 N Mccarthy Blvd; Milpitas CA 95035-5102
• Manufacturer Reason for Recall: On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On Nov 18, 2024, BD has identified through complaints an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure caused by BD FACSLyric Flow Cytometer may involve patient specimen loss and/ or delay to provide results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). Customers are instructed to continue normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use. Ensure the contents of this notification are read and understood. Immediately inspect your inventory for the specific catalog and power supply serial numbers listed above and follow the instructions listed under Actions for Clinical Users . Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification as per FDA requirement.
• Quantity in Commerce: 16 power supplies
• Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.
• Total Product Life Cycle: TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OYE