Beckman Coulter Biomedical GmbH

Munchen Bavaria, DE

Beckman Coulter Biomedical GmbH appears in FDA device records in Munchen Bavaria, DE. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 7 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 7
Registered establishments: 2

510(k) clearance history

FDA records hold 1 510(k) clearance for Beckman Coulter Biomedical GmbH in 2019.

Clearances by year, as a table

510(k) clearance decisions for Beckman Coulter Biomedical GmbH, by decision year
Year	Clearances
2019	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K190298	DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12	CDD	Substantially Equivalent	2019-10-04

Registered establishments

FDA registered establishments for Beckman Coulter Biomedical GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3006677029	3006677029	Beckman Coulter Biomedical GmbH	Sauerbruchstr. 50, Munchen Bavaria 81377 DE	2026	CDD CGN DBF JJE JLW JQP
3021394862	3021394862	Beckman Coulter Biomedical GmbH	Kuehler Weg 1, Baierbrunn Bavaria 82065 DE	2026	JJE JQP

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2834-2026	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	Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.	Class II	2026-04-29	Open, Classified
Z-2980-2024	PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.	The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.	Class II	2024-07-17	Open, Classified
Z-2979-2024	PE Centrifuge, REF: B36365, a component of the Power Express	The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.	Class II	2024-07-17	Open, Classified
Z-2978-2024	Power Express, REF B90918	The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.	Class II	2024-07-17	Open, Classified
Z-2145-2023	Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly	A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results	Class II	2023-06-02	Open, Classified
Z-2144-2023	Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly	A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results	Class II	2023-06-02	Open, Classified
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.	The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system .	Class II	2020-06-17	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain