Beckman Coulter Recalls

17 recalls found for Beckman Coulter. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter AU5800 Chemistry Analyzer Recall for 47 Units Over Calibration Delay Issues (2026)

Beckman Coulter Mishima K.K. recalled 47 AU5800 chemistry analyzers sold nationwide in the United States after a software delay can cause calibration and reagent databases to fail to open. The issue occurs when a calibration monitor using Microsoft SQL Server 2022 Express remains open for more than 15 minutes, potentially halting analysis. Healthcare facilities should stop using the devices and (a

Beckman Coulter
A delay
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Sample Preparation System Recalled for Software Error

Beckman Coulter recalled 50 units of the CellMek SPS Sample Preparation System on December 23, 2025. A software error causes sample dispensation issues leading to potential sample loss and incorrect diagnoses. Healthcare providers should stop using the device immediately.

Beckman Coulter
Sample preparation
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls UniCel Dxl 600 Analyzers Over Restart Issue

Beckman Coulter recalled 1,272 UniCel Dxl 600 analyzers on November 26, 2025. A communication issue may prevent the devices from restarting after shutdown, delaying test results. The recall affects multiple countries worldwide.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 6,457 Immunoassay Analyzers Over Restart Issues

Beckman Coulter recalled 6,457 UniCel Dxl 800 analyzers on November 26, 2025, due to potential restart failures. The defect prevents the devices from transitioning to Ready mode, delaying patient sample processing. Healthcare providers must stop using the devices immediately and follow recall instructions.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls Diluent Due to Elevated Platelet Counts

Beckman Coulter recalled 76,098 units of COULTER DxH Diluent on November 10, 2025. The recall affects specific lots contributing to elevated platelet background counts in analyzers. Healthcare providers and patients must stop using this product immediately.

Beckman Coulter
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 160 DxC 500i Modules and DxI 9000 Analyzers in 2025 Recall

Beckman Coulter recalls 160 DxC 500i Clinical Analyzer Modules and the DxI 9000 Access Immunoassay Analyzer worldwide after a software anomaly could misapply manual dilution factors. The defect affects samples already in progress using the same Sample ID. Stop using the devices immediately and follow the recall instructions. Beckman Coulter will provide instructions via the recall process.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 571 DxI 9000 Immunoassay Analyzers and DxC 500i (2025)

Beckman Coulter recalled 571 DxI 9000 Access Immunoassay Analyzers and DxC 500i Clinical Analyzers distributed worldwide. A software anomaly may prevent correct application of manual dilution factors for tests already in progress on the same Sample ID. Labs should stop using the devices immediately and follow recall instructions.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter MicroScan Neg Multidrug Resistant MIC 1 C32368 Recall Expands Internationally (2025)

Beckman Coulter recalled three boxes of MicroScan Neg Multidrug Resistant MIC 1 panels distributed internationally, including Poland. A manufacturing issue caused incorrect processing in in vitro multidrug resistance testing. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions for recall communications.

Beckman Coulter
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Phosphorus Reagent Recall: 2,146 Units for Calibration Failures

Beckman Coulter recalled 2,146 units of the SYNCHRON Systems Phosphorus (PHOSm) Reagent due to calibration failures that may delay patient results. Specific reagent lots may not function properly before their expiration date. Healthcare providers and patients must stop using these reagents immediately and follow manufacturer instructions.

Beckman Coulter
Specific SYNCHRON
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter UniCel DxH 800 Hematology Analyzers Recalled for High Hemoglobin Readings in High-WB

Beckman Coulter recalled the UniCel DxH 800 COULTER Cellular Analysis System configured with the Led HGB photometer. The recall affects models B24802, 629029, and B63322 and related configurations. A design-linked issue can yield erroneously high hemoglobin results when samples have elevated white blood cell counts. Stop using the device and follow the manufacturer’s recall instructions. Contact a

Beckman Coulter
Hematology analyzers
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter DxH 900 COULTER Hematology Analyzer Recalled for Inaccurate Hemoglobin Results

Beckman Coulter recalled hematology analyzers configured with HGB photometers after reports of erroneously high hemoglobin results in samples with elevated WBC counts. The recall covers DxH 900 systems worldwide. Stop using the device immediately and follow manufacturer instructions. Contact Beckman Coulter or a healthcare provider for guidance.

Beckman Coulter
Hematology analyzers
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter UniCel DxH 690T Hematology Analyzer Recall Over HGB Photometer (2025)

Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System configured with the LED HGB Photometer REF C34520. The hematology analyzer may produce erroneously high hemoglobin results on samples with elevated white blood cell counts. Labs should stop using the device immediately and follow Beckman Coulter's recall instructions.

Beckman Coulter
Hematology analyzers
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter UniCel DxH 600 Hematology Analyzer with HGB Photometer Recalled in 2025

Beckman Coulter recalled the UniCel DxH 600 COULTER Hematology Analyzer configured with an LED HGB Photometer, distributed to laboratories worldwide. The device may produce erroneously high hemoglobin results when WBC counts are elevated. Labs and healthcare providers should stop using the device immediately and follow Beckman Coulter's recall instructions.

Beckman Coulter
Hematology analyzers
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter DxC 500i Clinical Analyzer Modules Recalled for Processing Delays (2025)

Beckman Coulter has issued a recall for 116 DxC 500 AU Module with ISE and DxC 500i components sold internationally. The recall date is 2025-08-04. A processing fault can cause the Clinical Chemistry test to stay In Progress when an Immunoassay test is run between CC tests. Delays may occur. Stop using the device and contact Beckman Coulter for instructions.

Beckman Coulter
On a
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter MicroScan Neg MIC 56 Panels Recalled for Contamination Risk (2026)

Beckman Coulter recalled 685 boxes of MicroScan Neg MIC 56 panels distributed nationwide to U.S. healthcare facilities after contamination was reported in wells. Contamination could lead to unreliable antimicrobial susceptibility and organism-identification results. Health care providers should stop using the panels and follow Beckman Coulter recall instructions immediately.

Beckman Coulter
Due to
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Brand Statistics

Total Recalls
17
Pages
1

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