BD FACSLyric Flow Cytometer Power Supply May Fail During Use
BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.
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 recalls a risk-of-harm product (clinical laboratory device that could emit fumes and cause respiratory effects) where injury has not yet been reported. Per the severity rubric, such products score at most 3 (High) when no illnesses or injuries have been documented.
Plain-English summary
The BD FACSLyric flow cytometer is a clinical laboratory instrument used for biospecimen analysis. The device is being recalled due to failure of the power supply module (part number 650781) on certain units. The power supply may fail to power on or cause the instrument to shut down unexpectedly.
Power supply failures occurring during laboratory operation could release fumes, creating an inhalation hazard for laboratory staff that may result in shortness of breath or coughing. Additionally, device failure could delay or prevent patient test results and may necessitate additional biospecimen collection from patients, with associated risks including bruising, pain, and bleeding.
The recall affects 20 power supplies with specific serial numbers beginning with V2309, V2318, and V2330. The devices have been distributed nationwide throughout the United States and internationally in China, Costa Rica, Singapore, and Thailand.
Laboratory facilities should immediately inspect their inventory for the specific device catalog numbers (662876) and power supply serial numbers identified in the FDA notification. BD issued instructions for clinical users on November 20, 2024. Facilities should refer to those instructions and contact BD with any questions about their equipment.
The recalled product
- Product
- Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 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 cy
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- power-supply-failure
- device-malfunction
- inhalation-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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