Beckman Coulter Recalls

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

HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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HIGHFDA DEVICE

Beckman Coulter Recalls DxC 500i Clinical Analyzers Over Software Errors

Beckman Coulter recalled 160 DxC 500i Clinical Analyzer modules on September 19, 2025. A software anomaly may cause incorrect manual dilution factors, leading to false patient results. Healthcare providers must stop using the devices immediately to avoid erroneous diagnoses.

Beckman Coulter
Beckman Coulter
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HIGHFDA DEVICE

Beckman Coulter Recalls Immunoassay Analyzer Over Software Flaw

Beckman Coulter recalled 571 DxI 9000 Access Immunoassay Analyzers on September 19, 2025, due to a software anomaly. The defect may lead to inaccurate patient test results affecting diagnoses. Healthcare providers must stop using the device immediately and follow recall instructions.

Beckman Coulter
Beckman Coulter
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HIGHFDA DEVICE

Beckman Coulter Reagents Recalled Due to Calibration Failure

Beckman Coulter recalled 2,146 units of SYNCHRON Systems Phosphorus reagents on September 3, 2025. The affected lots may fail calibration before expiration, delaying patient results. Healthcare providers must stop using the product immediately.

Beckman Coulter
Specific SYNCHRON
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HIGHFDA DEVICE

Beckman Coulter Recalls Hematology Analyzers Over High HGB Results

Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System on August 13, 2025. Erroneously high hemoglobin results may occur in patients with elevated white blood cell counts. Healthcare providers and patients must stop using the device immediately.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Beckman Coulter Recalls Hematology Analyzers Due to High HGB Risk

Beckman Coulter recalled its UniCel DxH 800 COULTER Cellular Analysis System on August 13, 2025. This recall affects devices that may produce inaccurately high hemoglobin results in patients with high white blood cell counts. The recall impacts worldwide distribution including numerous states in the U.S. and many countries.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Beckman Coulter Recalls Hematology Analyzers Over High HGB Risk

Beckman Coulter recalled the UniCel DxH 600 Cellular Analysis System on August 13, 2025. The devices may produce erroneously high hemoglobin results in patients with elevated white blood cell counts. This recall affects medical facilities worldwide, including the United States.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Beckman Coulter Hematology Analyzer Recalled for High HGB Risk

Beckman Coulter recalled the UniCel DxH 900 COULTER Cellular Analysis System on August 13, 2025, due to erroneous high hemoglobin results. The devices may misreport hemoglobin levels on samples with elevated white blood cell counts. This recall affects devices distributed worldwide, including the U.S.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Beckman Coulter Recalls DxC 500i Analyzer Modules Over Processing Delays

Beckman Coulter recalled 116 DxC 500i Clinical Analyzer modules on August 4, 2025, due to potential processing delays. The defect may impact the accuracy of test results when ordering certain tests simultaneously. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Beckman Coulter
On a
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HIGHFDA 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
14
Pages
1