{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211024", "product_res_number": "Z-0749-2025", "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": "FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181", "code_info": "Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted\n\nCatalog Number: 663518\nUDI-DI code: 00382906635181\nInstrument Serial Numbers / Power Supply Serial 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00465\tV23180064", "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": "139 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": { "device_name": "Flow Cytometric Reagents And Accessories.", "medical_specialty_description": "Hematology", "regulation_number": "864.5220", "device_class": "2", "k_number": [ "K162897", "K232600", "K121445", "K141468", "K130373", "K141932", "K201814", "K170974" ], "registration_number": [ "3003244710", "1064130", "8043379", "3003589956", "8023018", "3016954941", "3008494306", "3027394506", "1017835", "1061932", "3008352382" ], "fei_number": [ "3003244710", "3002684533", "3003413192", "3003589956", "3016954941", "3008494306", "3000203293", "3027394506", "1017835", "3002807272", "3008352382" ] } } ] }