Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
FDA product code PER · Class I (low risk) · 21 CFR 862.2750 · Clinical Chemistry
Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.
3510(k) clearances
0PMA approvals
10recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131301 | BD Facs Sample Prep Assistant IIIPER · Traditional | Becton, Dickinson & CO | 08/02/2013SE |
| K130253 | Tq-Prep Workstation, Prepplus 2 WorkstationPER · Traditional | Beckman Coulter, Inc. | 07/15/2013SE |
| K050191 | Modification to BD Facscanto System with BD Facscanto Clinical SoftwarePER · Special | Becton, Dickinson & CO | 02/22/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1235-2026 Class II | CellMek SPS Sample Preparation System, REF: C44603, with softwareSample preparation system designed to automate staining, lysing, cell washing has a software error that… | Beckman Coulter, Inc. | 12/23/2025Open, Classified |
| Z-0412-2026 Class II | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and…Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device… | Beckman Coulter, Inc. | 09/08/2025Open, Classified |
| Z-1113-2025 Class II | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog…Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the… | Sysmex America, Inc. | 01/06/2025Open, Classified |
| Z-0009-2025 Class II | BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet…Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay:… | Becton, Dickinson and Company, BD Bio… | 08/12/2024Open, Classified |
| Z-2687-2020 Class II | Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a…Insufficient amount of antibody without an error message or alarm | Sysmex America, Inc. | 07/06/2020Terminated |
| Z-2358-2020 Class II | BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended…The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to… | Becton, Dickinson and Company, BD Biosciences | 07/08/2019Terminated |
| Z-2357-2020 Class II | BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD…The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to… | Becton, Dickinson and Company, BD Biosciences | 07/08/2019Terminated |
| Z-2356-2020 Class II | BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system…The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes… | Becton, Dickinson and Company, BD Biosciences | 07/08/2019Terminated |
| Z-2690-2017 Class II | Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used…When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow… | Beckman Coulter Inc. | 05/22/2017Terminated |
| Z-2689-2017 Class II | Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a…When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow… | Beckman Coulter Inc. | 05/22/2017Terminated |