{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211021", "product_res_number": "Z-0746-2025", "event_date_initiated": "2024-11-01", "event_date_posted": "2024-12-23", "recall_status": "Open, Classified", "res_event_number": "95729", "product_code": "OYE", "k_numbers": [ "K170974", "K201814" ], "product_description": "Device Description: \nFACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763\n\nThe K170974 clearance document describes the device as follows:\n\nThe BD FACSLyric\" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical \nconfigurations) systems consist of a flow cytometer, sheath tank, waste tank, and a \ncomputer workstation. System options include an automated FACS Universal Loader and \na barcode reader.\nThe BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part \nof four available manufactured instrument configurations.\nBD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser\nBD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser\nBD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser\nBD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser\nThe lower level configurations are upgradeable to higher level configurations by adding \nfilters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm \nlasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence \nchannels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO).\nAll optical configurations of the FACSLyric share the same dimensions: 22.8 inches in \nheight by 24.93 inches in width by 22.8 inches in depth.\n\nThe K201814 clearance document describes the device as follows:\n\nRefer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer.\nThe modified BD FACSLyric Flow Cytometer consists of the following components.\n\" FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations)\n\" FACSuite Clinical Software (version 1.4)\n\" Modified FACS Universal Loader: updated shaker and modification to the door lock and \nsensor connections\n\" Modified CMS firmware\n\n\nBD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system \nconsists of all the above components as FACSLyric Flow Cytometer and additionally contain:\n\" BD FACSDuet Sample Preparation system physically and data integrated with the BD \nFACSLyric Flow Cytometer\n\" FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution.\n\" Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket", "code_info": "Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted.\n\nCatalog Number: 662876\nUDI-DI code: 00382906628763\nInstrument Serial Numbers / Power Supply Serial Numbers:\nZ662876000065\tV23300165\nZ662876000044\tV23090245\nZ662876000045\tV23090338\nZ662876000048\tV23180201\nZ662876000047\tV23180258\nZ662876000051\tV23180476\nZ662876000050\tV23180466\nZ662876000049\tV23180113\nZ662876000052\tV23180415\nZ662876000053\tV23180190\nZ662876000056\tV23300354\nZ662876000055\tV23300347\nZ662876000057\tV23300249\nZ662876000059\tV23300174\nZ662876000061\tV23300274\nZ662876000062\tV23300132\nZ662876000060\tV23300286\nZ662876000063\tV23300163\nZ662876000066\tV23300232\nZ662876000054\tV23300408", "firm_fei_number": "3027394506", "recalling_firm": "Becton, Dickinson and Company, BD Bio Sciences", "address_1": "155 N Mccarthy Blvd", "city": "Milpitas", "state": "CA", "postal_code": "95035-5102", "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.", "root_cause_description": "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.", "product_quantity": "20 power supplies", "distribution_pattern": "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.", "openfda": { "k_number": [ "K170974", "K141932", "K201814", "K162897", "K121445", "K232600", "K141468", "K130373" ], "device_name": "Flow Cytometric Reagents And Accessories.", "medical_specialty_description": "Hematology", "regulation_number": "864.5220", "device_class": "2", "registration_number": [ "3003244710", "3027394506", "8023018", "1061932", "8043379", "3003589956", "3016954941", "1064130", "1017835", "3008494306", "3008352382" ], "fei_number": [ "3003244710", "3027394506", "3003413192", "3003589956", "3000203293", "3016954941", "1017835", "3002807272", "3002684533", "3008494306", "3008352382" ] } } ] }