Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FACSLyric 2L4C Instrument US Recalled by Becton, Dickinson and Company, BD Bio Sciences Due to On October 18, 2024, BD has identified through...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Becton, Dickinson and Company, BD Bio Sciences directly.
Affected Products
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.
Quantity: 15 power supplies
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Becton, Dickinson and Company, BD Bio Sciences
Becton, Dickinson and Company, BD Bio Sciences has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report