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Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
FDA product code PER · Class 1 · Clinical Chemistry
11
Registered devices
181
Adverse events
10
Recalls
3
510(k) clearances
Devices with this code
PrepPlus 2 — Beckman Coulter, Inc.FACS — Becton, Dickinson And CompanyBD FACSDuet — Becton, Dickinson And CompanyBD FACSDuet — Becton, Dickinson And CompanyFACS — Becton, Dickinson And CompanyTQ-Prep Workstation — Beckman Coulter, Inc.Cellmek — Beckman Coulter, Inc.BD FACSCanto™ — BECTON, DICKINSON AND COMPANYBD FACSCanto™ — BECTON, DICKINSON AND COMPANYFACS — Becton, Dickinson And CompanySample Preparation System PS-10 — SYSMEX CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-23 | Beckman Coulter, Inc. | Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube |
| 2025-09-08 | Beckman Coulter, Inc. | Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassett |
| 2025-01-06 | Sysmex America, Inc. | Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS- |
| 2024-08-12 | Becton, Dickinson and Company, BD Bio Sciences | Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher t |
| 2020-07-06 | Sysmex America, Inc. | Insufficient amount of antibody without an error message or alarm |
| 2019-07-08 | Becton, Dickinson and Company, BD Biosciences | The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 p |
| 2019-07-08 | Becton, Dickinson and Company, BD Biosciences | The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in |
| 2019-07-08 | Becton, Dickinson and Company, BD Biosciences | The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in |
| 2017-05-22 | Beckman Coulter Inc. | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute |
| 2017-05-22 | Beckman Coulter Inc. | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute |
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