FACSLyric 2L6C Instrument (BD) – power supply module issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 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
Brand
Becton, Dickinson and Company, BD Bio Sciences
Lot Codes / Batch Numbers
Power supply part number 650781 with serial numbers beginning with V2309, V2318
Products Sold
Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted. Catalog Number: 662876 UDI-DI code: 00382906628763 Instrument Serial Numbers / Power Supply Serial Numbers: Z662876000065 V23300165 Z662876000044 V23090245 Z662876000045 V23090338 Z662876000048 V23180201 Z662876000047 V23180258 Z662876000051 V23180476 Z662876000050 V23180466 Z662876000049 V23180113 Z662876000052 V23180415 Z662876000053 V23180190 Z662876000056 V23300354 Z662876000055 V23300347 Z662876000057 V23300249 Z662876000059 V23300174 Z662876000061 V23300274 Z662876000062 V23300132 Z662876000060 V23300286 Z662876000063 V23300163 Z662876000066 V23300232 Z662876000054 V23300408
Becton, Dickinson and Company, BD Bio Sciences is recalling Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K due to On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part n. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026