Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
K060201
Cited as predicate by: K191562
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-01-17 | NAI | No action indicated | Beckman Coulter, Inc. | 0 |
| 2025-01-17 | NAI | No action indicated | Beckman Coulter, Inc. | 0 |
| 2024-03-15 | WL | Warning Letter | Beckman Coulter, Inc. | — |
| 2024-03-15 | WL | Warning Letter | Beckman Coulter, Inc. | — |
| 2023-12-11 | OAI | Official action indicated | Beckman Coulter, Inc. | 0 |
| 2023-12-11 | OAI | Official action indicated | Beckman Coulter, Inc. | 0 |
| 2021-10-28 | VAI | Voluntary action indicated | Beckman Coulter, Inc. | 2 |
| 2021-10-28 | VAI | Voluntary action indicated | Beckman Coulter, Inc. | 2 |
| 2021-08-05 | NAI | No action indicated | Beckman Coulter Inc. | 0 |
| 2021-08-05 | NAI | No action indicated | Beckman Coulter Inc. | 0 |
| 2019-10-30 | NAI | No action indicated | Beckman Coulter Inc. | 0 |
| 2019-10-30 | NAI | No action indicated | Beckman Coulter Inc. | 0 |
| 2017-10-16 | VAI | Voluntary action indicated | Beckman Coulter, Inc. | 4 |
| 2017-10-16 | VAI | Voluntary action indicated | Beckman Coulter, Inc. | 4 |
| 2017-02-02 | VAI | Voluntary action indicated | Beckman Coulter GmbH | 2 |
| 2016-05-20 | NAI | No action indicated | Beckman Coulter Inc | 0 |
| 2016-01-27 | VAI | Voluntary action indicated | Beckman Coulter, Inc. | 2 |
| 2016-01-27 | VAI | Voluntary action indicated | Beckman Coulter, Inc. | 2 |
| 2015-03-11 | VAI | Voluntary action indicated | Beckman Coulter, Inc. | 1 |
| 2015-03-11 | VAI | Voluntary action indicated | Beckman Coulter, Inc. | 1 |
| 2015-02-05 | NAI | No action indicated | Beckman Coulter Inc | 0 |
| 2015-02-05 | NAI | No action indicated | Beckman Coulter Inc | 0 |
| 2011-11-01 | WL | Warning Letter | Beckman Coulter, Inc. | — |
| 2011-11-01 | WL | Warning Letter | Beckman Coulter, Inc. | — |
| 2011-08-01 | WL | Warning Letter | Beckman Coulter Inc. | — |
| 2011-08-01 | WL | Warning Letter | Beckman Coulter Inc. | — |
| 2010-06-21 | WL | Warning Letter | Beckman Coulter Inc. | — |
| 2010-06-21 | WL | Warning Letter | Beckman Coulter Inc. | — |
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