BD Bio Sciences recalls FACSLyric 3L12C flow cytometers with specific power supply serial numbers due to potential failure causing shortness of breath from fumes. Affected units may need inspection and follow-up actions.
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.
BD Bio Sciences is recalling certain FACSLyric 3L12C flow cytometers because their power supply modules can fail, potentially causing the instrument to stop working or stay on. This failure could lead to laboratory staff inhaling fumes and experiencing shortness of breath or coughing during use.
The power supply module (part number 650781) in the recalled flow cytometers can fail, causing the instrument to stop working or remain on. If this failure occurs during laboratory use, it may release fumes that laboratory staff could inhale, leading to shortness of breath or coughing.
Laboratory staff using the affected BD FACSLyric flow cytometers are most at risk of inhaling fumes and experiencing shortness of breath or coughing if the power supply fails during operation. Patients may also face delays in testing or additional procedures if the instrument fails.
Check for the specific catalog number 663518 and power supply serial numbers starting with V2309, V2318, or V2330. The instrument serial numbers and power supply serial numbers are listed in the notification letter.
Check your instrument's power supply serial number to see if it starts with V2309, V2318, or V2330.
If your instrument is not affected, follow the manufacturer's instructions for normal operation.
The affected power supply part number is 650781 (Power Module AC-DC 250W 12/24V M3S4S6).
Inspect your power supply serial number. If it starts with V2309, V2318, or V2330, contact BD Bio Sciences for further instructions.
The recall states that failure could lead to shortness of breath or coughing if fumes are inhaled during laboratory use, but it does not specify a risk of serious injury.
We’ve drafted a message you can send BD Bio Sciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0749-2025 — BD Bio Sciences BD Bio Sciences Hello, I own a BD Bio Sciences that is covered by recall Z-0749-2025 from BD Bio Sciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
