BD FACSLyric Flow Cytometer Power Supply Module Failure Risk
BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.
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 medical device recall with potential for harmful fume exposure to laboratory staff and patient specimen loss. No illnesses or injuries reported in the source. Meets rubric criterion for risk-of-harm product without reported injury.
Plain-English summary
BD is recalling power supply modules on FACSLyric 3L10C flow cytometers due to potential failures that could prevent the instruments from powering on or remaining powered on. The issue was identified on October 18, 2024, following customer complaints and an increase in field failures. The affected component is the power module (part number 650781, AC-DC 250W).
The potential failure could expose laboratory staff to inhalation of fumes that may cause shortness of breath or coughing during work hours. Patients may also be asked to return for additional biospecimen collection procedures if specimen loss occurs, with associated risks including bruising, pain, and bleeding. Testing results may be delayed.
Approximately 49 power supplies have been distributed worldwide, including to multiple U.S. states and internationally to China, Costa Rica, Singapore, and Thailand. Affected instruments have power supply serial numbers beginning with V2309, V2318, or V2330.
Customers should immediately inspect their inventory for affected catalog and serial numbers listed in the FDA notification letter dated November 20, 2024, and follow the provided instructions for clinical users.
The recalled product
- Product
- FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- power-failure
- fume-inhalation
- respiratory-hazard
- specimen-loss
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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