Beckman Coulter Biomedical GmbH
Beckman Coulter Biomedical GmbH has 4 FDA enforcement events on this register (7 product records) between 2020 and 2026: 4 device; the busiest year was 2020 with 1.
0% of its events are Class I; the most common class is Class II (4). 3 events are listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 29 Apr 2026 | REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections | Device | Class II | 1 | Ongoing |
| 17 Jul 2024 | Power Express, REF B90918 | Device | Class II | 3 | Ongoing |
| 2 Jun 2023 | Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly | Device | Class II | 2 | Ongoing |
| 17 Jun 2020 | DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis.… | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Beckman Coulter Biomedical GmbH had?
4 enforcement events (7 product records) on this register, 2020–2026: 4 device.
Are any Beckman Coulter Biomedical GmbH recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are Beckman Coulter Biomedical GmbH recalls?
4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.