Data / Medical devices / Germany / Beckman Coulter Biomedical GmbH
Beckman Coulter Biomedical GmbH: FDA-registered device maker in Munchen Bavaria, Germany, 3 510(k) clearances
Beckman Coulter Biomedical GmbH is registered with the FDA (registration 3006677029) in Munchen Bavaria, Germany. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 4, 2019. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006677029
- Address
- Sauerbruchstr. 50, Munchen Bavaria, Germany, 81377
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Specification developer
- First device listed
- October 4, 2000
- Registered through
- 2026
- Brand names listed
- A11036 Power Processor Sample Processing System, A18894 Automate 800 Sample Processing System, A18896 Automate 600 Sample Processing System, AutoMate 1200 Sample Processing System, AutoMate 1250 Sample Processing System, AutoMate 2500 Sample Processing System, AutoMate 2550 Sample Processing System, B05033 Power Link and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Folic, Radioimmunoassay | CGN | 2 | Specification developer | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Specification developer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Specification developer | accessdata.fda.gov |
| Ferritin, Antigen, Antiserum, Control | DBF | 2 | Specification developer | accessdata.fda.gov |
| Radioassay, Vitamin B12 | CDD | 2 | Specification developer | accessdata.fda.gov |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 4, 2019 | K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 | CDD | Substantially Equivalent | Beckman Coulter Biomedical GmbH | accessdata.fda.gov |
| September 16, 2014 | K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents | CDD | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| May 11, 2011 | K110413 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS | CDD | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 29, 2026 | 98927 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 17, 2024 | 95064 | Class II | Ongoing | 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 ma | accessdata.fda.gov |
| June 2, 2023 | 92484 | Class II | Ongoing | 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 | accessdata.fda.gov |
| June 17, 2020 | 85874 | Class II | Terminated | 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 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Acid, Folic, Radioimmunoassay
- All makers of Ferritin, Antigen, Antiserum, Control
- All makers of Radioassay, Vitamin B12
- All makers of Radioimmunoassay, Thyroid-Stimulating Hormone
- All makers of Calculator/Data Processing Module, For Clinical Use
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.