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RecallWatchMedical Device Safety
Class IIOngoingZ-0749-2025

Becton, Dickinson And Company, BD Bio Sciences recalls FACSLyric 3L12C Instrument RUO

Becton, Dickinson and Company, BD Bio SciencesMilpitas, CA, United StatesReported Jan 1, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI00382906635181
    UDI-DI codeCatalog # Number
    388 affected lots
    V2309V2318V233066351800382906635181MP6635180000004V23180079MP6635180000008
    +380 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

What the firm is doing

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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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