BD FACSLyric Flow Cytometer Recalled Due to Unsupported Operating System Configuration
Becton, Dickinson and Company is recalling three BD FACSLyric flow cytometers because they were installed with an unsupported Windows 10 operating system configuration.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software configuration error rather than a direct physical hazard.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences, is recalling three BD FACSLyric 3L 10C flow cytometers equipped with FACSuite Clinical Software v1.1.1. The recall was initiated after a customer site was identified where the devices were installed on a computer workstation running the Windows 10 operating system.
The recall is necessary because the Windows 10 operating system is not a released configuration for clinical use of this device; it is released for research use only. The affected units are identified by specific serial numbers and UDI codes listed in the recall documentation.
The recall is limited to US distribution in Maryland. Users of these devices should contact the manufacturer for further instructions regarding the unsupported configuration.
The recalled product
- Product
- BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support…
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Category
- Medical Device — Flow Cytometer
- Hazard
- Affected units
- 3
Distribution
Distributed in 1 state:
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