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-0748-2025
• Recall Event ID: 95729
• 510(K)Number: K170974 K201814
• Product Classification: Flow cytometric reagents and accessories. - Product Code OYE
• Product: FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 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: 662878 UDI-DI code: 00382906628787 Instrument Serial Numbers / Power Supply Serial Numbers: Z662878000426 V23180200 Z662878000412 V23180272 Z662878000410 V23180312 Z662878000046 UNK Z662878000319 UNK Z662878000367 V23090032 Z662878000373 V23090334 Z662878000370 V23090030 Z662878000371 V23090076 Z662878000377 V23090329 Z662878000369 V23090021 Z662878000375 V23090010 Z662878000372 V23090176 Z662878000378 V23090048 Z662878000380 V23090136 Z662878000374 V23090354 Z662878000383 V23090365 Z662878000379 V23090361 Z662878000401 V23180013 Z662878000382 V23090191 Z662878000381 V23090196 Z662878000421 V23180001 Z662878000387 V23090396 Z662878000420 V23180150 Z662878000425 V23180449 Z662878000399 V23180007 Z662878000400 V23090381 Z662878000422 V23090460 Z662878000386 V23090409 Z662878000388 V23090374 Z662878000390 V23090408 Z662878000368 V23090036 Z662878000431 V23300473 Z662878000432 V23300472 Z662878000389 V23090387 Z662878000423 V23180014 Z662878000454 V23300221 Z662878000413 V23180117 Z662878000376 V23090122 Z662878000455 V23300323 Z662878000453 V23300273 Z662878000411 V23180096 Z662878000385 V23090172 Z662878000384 V23090499 Z662878000394 V23090394 Z662878000395 V23180408 Z662878000434 V23180118 Z662878000435 V23300149 Z662878000111 UNK
• 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: 49 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