Munchen, Germany
Beckman Coulter Biomedical GmbH recalls
4 recalls recorded since 2018, most recently on 29 April 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 April 2026
- Reason
- 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.
- Distribution
- U.S.: FL, GA, IL, MI, and PA O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Ongoing Class II Medical devices
- Recall started
- 17 July 2024
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2980-2024, Z-2978-2024, Z-2979-2024
- PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
- Power Express, REF B90918
- PE Centrifuge, REF: B36365, a component of the Power Express
Ongoing Class II Medical devices
- Recall started
- 2 June 2023
- Reason
- 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
- Distribution
- US: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, United K
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2145-2023, Z-2144-2023
- Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
- Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Terminated Class II Medical devices
- Recall started
- 17 June 2020
- Terminated
- 24 August 2022
- Reason
- 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 .
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Illinois, Ohio, Pennsylvania, and West Virginia. The countries of Australia, Canada, China, Czech Republic, France, Israel, Italy, Germany, Switzerland, Spain, Netherlands, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.