BD FACSLyric 2L4C Flow Cytometer Power Supply Failure Recall
BD FACSLyric 2L4C flow cytometers with specific power supplies (part 650781) may fail to power on or stay on. Potential fume inhalation could cause respiratory symptoms in laboratory staff.
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: This is an FDA Class II medical device recall with identified potential for harm (power failure and respiratory hazard from fume inhalation) in a laboratory setting. Although no illnesses or injuries have been reported, the hazard is real and risk-of-harm criteria apply, placing this at severity level 3 per the rubric.
Plain-English summary
BD FACSLyric 2L4C flow cytometer laboratory instruments with power supply module part number 650781 are being recalled due to failure risk. The affected power supplies have serial numbers beginning with V2309, V2318, and V2330.
On October 18, 2024, BD identified through customer complaints and increased field failures that the power supply modules can fail, causing instruments to fail to power on or remain powered on. The power supply failure creates a potential hazard of fume inhalation that could result in respiratory effects including shortness of breath or coughing for laboratory staff working near the instrument when failure occurs.
Laboratory users of affected instruments are at risk. Additionally, patients may experience delays or need to return for additional biospecimen collection procedures if specimen loss or testing delays occur due to instrument downtime, with associated risks of bruising, pain, or bleeding.
BD notified customers through a notification letter sent November 20, 2024, instructing them to inspect inventory for the affected catalog and power supply serial numbers and to follow the guidance for clinical users provided in that notification.
The recalled product
- Product
- 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)
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- power-failure
- fume-inhalation
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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