Medical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling power supply modules in FACSLyric flow cytometers that may fail to power on or remain powered. Failure could expose lab staff to fumes and cause patient specimen loss or delayed test results.
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 with potential respiratory hazard (inhalation of fumes leading to shortness of breath and coughing) and patient care impact (specimen loss and delayed results). No illnesses or injuries reported. Classified as High per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
BD has issued a recall for power supply modules in its FACSLyric flow cytometer instruments. The affected power supplies (part number 650781) were identified in October 2024 following customer complaints and increased field failures. Affected instruments have catalog number 662877 with specific power supply serial numbers beginning with V2309, V2318, and V2330.
The power supply failure can prevent instruments from powering on or remaining powered. This poses potential risks to laboratory staff, including inhalation of fumes followed by shortness of breath or coughing if failure occurs during lab operation. Additionally, failed instruments may require patients to return for additional biospecimen collection procedures, which carry associated risks such as bruising, pain, and bleeding.
Lab-affected facilities may also experience specimen loss or delays in providing test results. The recall affects instruments distributed worldwide, including across the United States and internationally in China, Costa Rica, Singapore, and Thailand.
Customers received notification on November 20, 2024, with instructions to inspect their inventory for affected serial numbers and follow the clinical user actions provided by BD. Laboratories should continue normal operation while inspecting for the specific equipment listed in the recall notification.
The recalled product
- Product
- FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 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 tan
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Category
- Medical Device — Lab Equipment
- Hazard
- power-supply-failure
- respiratory-hazard
- specimen-loss
- delayed-test-results
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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