Beckman Coulter Biomedical GmbH
Beckman Coulter Biomedical GmbH holds FDA 510(k) medical device clearance, cleared in 2019, with 6 FDA device recalls on record.
Top product codes for Beckman Coulter Biomedical GmbH
FDA recalls by Beckman Coulter Biomedical GmbH
- Z-2978-2024 — Power Express, REF B90918
- Z-2980-2024 — PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
- Z-2979-2024 — PE Centrifuge, REF: B36365, a component of the Power Express
- Z-2144-2023 — Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
- Z-2145-2023 — Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
- Z-2983-2020 — 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. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Beckman Coulter Biomedical GmbH
Data sourced from openFDA. This site is unofficial and independent of the FDA.