Skip to content

Beckman Coulter Biomedical GmbH

Germany Last updated 25 Oct 2026

Devices
8
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
76 ongoing

Catalogue8

FDA recalls7

Device pages show only the recalls that name the device or its 510(k)/PMA.

  • 2026

    • 29 Apr 2026 Z-2834-2026 Class II Ongoing 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.

  • 2024

    • 17 Jul 2024 Z-2978-2024 Class II Ongoing 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.
    • 17 Jul 2024 Z-2979-2024 Class II Ongoing 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.
    • 17 Jul 2024 Z-2980-2024 Class II Ongoing 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.

  • 2023

    • 2 Jun 2023 Z-2144-2023 Class II Ongoing 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
    • 2 Jun 2023 Z-2145-2023 Class II Ongoing 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

  • 2020

    • 17 Jun 2020 Z-2983-2020 Class II Terminated 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 .

About

Beckman Coulter Diagnostics helps healthcare professionals provide better patient care by delivering the accurate diagnostic information they need.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Beckman Coulter Biomedical GmbH have in the registry?

The registry currently lists 8 devices for Beckman Coulter Biomedical GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Beckman Coulter Biomedical GmbH's devices?

Among its 8 most recently registered devices, Beckman Coulter Biomedical GmbH has devices listed in EUDAMED (7 devices), FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Beckman Coulter Biomedical GmbH's devices fall under?

Among its 8 most recently registered devices, the classes recorded for Beckman Coulter Biomedical GmbH's devices are Class II and IVDR Class A. Each device page shows its own class and authorisation.

Are there FDA recall records for Beckman Coulter Biomedical GmbH?

FDA recall records list 7 recalls initiated by Beckman Coulter Biomedical GmbH, the most recent initiated on 2026-04-29. 6 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Beckman Coulter Biomedical GmbH in the registry?

The most recently registered devices listed for Beckman Coulter Biomedical GmbH include DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12, Pipette Tips, Tip Rack Filter - Pipette Tips and Secondary Round Bottom Tubes.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
50, Sauerbruchstr., Munich , Germany
Phone
+(1) 800-854-3633
PRRC contact
Franck Cheillan
EUDAMED SRN
DE-MF-000008041
FDA FEI number
3006677029