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PrepPlus 2
Beckman Coulter, Inc. · Model 378600 · UDI-DI 15099590638191
PER
Prescription
1
510(k) clearances
181
Adverse events
10
Recalls
14
Facilities
Description
COULTER PrepPlus 2
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 bottoms, which coul |
| 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: Cassette Type/List volume/c |
| 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-10 Sample Preparatio |
| 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 than volume in tube2, |
| 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 piercings guideline i |
| 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 the Instructions for |
| 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 the Instructions for |
| 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 counts on only the f |
| 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 counts on only the f |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.