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Beckman Coulter Biomedical Recalls
7 recalls on record · September 30, 2020 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2026Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager
Hazard: 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.
September 11, 2024Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Hazard: 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.
September 11, 2024Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls PE Centrifuge, REF: B36365, a component of the Power Express
Hazard: 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.
September 11, 2024Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls Power Express, REF B90918
Hazard: 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.
July 26, 2023Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Hazard: 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
July 26, 2023Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Hazard: 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
September 30, 2020Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sa
Hazard: 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 .