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-0745-2025
• Recall Event ID: 95729
• 510(K)Number: K170974 K201814
• Product Classification: Flow cytometric reagents and accessories. - Product Code OYE
• Product: FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. " It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
• Code Information: Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 662875 UDI-DI code: 00382906628756 Instrument Serial Numbers/ Power Supply Serial Numbers: Z662875000119 V23300114 Z662875000117 V23300192 Z662875000112 V23300098 Z662875000123 V23300321 Z662875000105 V23090179 Z662875000104 V23090157 Z662875000107 V23090507 Z662875000102 V23090029 Z662875000103 V23090114 Z662875000106 V23090177 Z662875000108 V23180127 Z662875000110 V23300074 Z662875000111 V23090430 Z662875000109 V23300294 Z662875000116 V23300051
• FEI Number: 3027394506
• 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: 15 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