BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential hazards including fume inhalation and respiratory symptoms. No illnesses or injuries have been reported. This meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton, Dickinson and Company is recalling 139 BD FACSLyric 3L12C flow cytometer power supplies (part number 650781) identified as defective on October 18, 2024.
The affected power supplies may fail to power on or stay on during operation. This can result in fume inhalation, shortness of breath, and coughing among laboratory staff. Additionally, affected instruments may require patients to return for repeat biospecimen collection procedures, which carry associated risks including bruising, pain, and bleeding. Patient specimens may be lost and test result reporting may be delayed.
The power supplies have been distributed nationwide in the United States and to customers in China, Costa Rica, Singapore, and Thailand. BD identified the issue through customer complaints and an increase in field failures and replacements.
Customers are instructed to immediately inspect their inventory for the specific catalog and power supply serial numbers identified in BD's notification letter (sent November 20, 2024). Follow the Actions for Clinical Users guidance provided by BD while continuing normal instrument operation.
The recalled product
- Product
- FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- electrical-failure
- fume-inhalation
- respiratory-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Power supply part number 650781 with serial numbers beginning with V2309
- V2318
Distribution
Distributed nationwide across the United States.
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