Beckman Coulter, Inc.

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

Beckman Coulter identified a manufacturing defect in certain MicroScan Neg MIC 3J antibiotic susceptibility test panels (Catalog C54814, Lot 2025-08-23). Some panels are missing a drug in one well and contain double the amount of antibiotics in others, which could produce inaccurate test results. No injuries have been reported.

Beckman Coulter has recalled MicroScan Neg MIC 56 antimicrobial susceptibility testing panels (Catalog C42464, Lot 2026-01-03) due to potential contamination in the test wells. These panels are used by laboratories to identify bacteria and test antibiotic resistance. Contaminated panels could produce inaccurate test results.

Beckman Coulter AU5800 chemistry analyzers with certain software configurations may experience errors that prevent the system from opening calibration databases after running for more than 15 minutes. When this happens, the analyzer stops working and requires a service technician to fix it, which can delay patient test results and treatment.

Certain Beckman Coulter DxC 700 AU clinical chemistry analyzers with specific software may stop working properly if left running for more than 15 minutes. The system will display database errors and stop analyzing patient samples. A technician from Beckman Coulter must visit your facility to install a software fix.

A software error in the Beckman Coulter CellMek SPS Sample Preparation System (model C44603, software version 2.3.90.0) causes samples to be dispensed incorrectly, potentially damaging the instrument and losing 60–100 microliters of sample fluid. This could lead to inaccurate test results and incorrect patient care decisions.

Beckman Coulter has recalled specific lots of COULTER DxH Diluent and COULTER DxH ECO Diluent used in blood cell analysis systems. These affected lots can produce inaccurate platelet count readings during daily quality checks, which may lead to unreliable test results.

Beckman Coulter's LDL Cholesterol OSR6x96 reagent may give inaccurate test results when patients have high triglyceride levels (above 1500 mg/dL). The test can overestimate LDL cholesterol by up to 29% in some samples, which could affect patient care decisions.

Beckman Coulter UniCel Dxl 800 analyzers (part numbers 973100, A71456, A71457, A25288) may fail to restart after shutdown due to a communication issue. When this happens, the analyzer cannot initialize or process patient samples, QCs, or calibrators, which delays test results.

Certain Beckman Coulter UniCel DxL 600 analyzers may fail to restart properly after shutdown due to a communication issue. When this happens, the analyzer cannot process patient samples or quality control checks, which can delay test results.

Beckman Coulter Bicarbonate Reagent (catalog numbers OSR6137, OSR6237, OSR6637) used in laboratory analyzers may produce falsely high bicarbonate test results. This happens because a substance in blood samples called Lactate Dehydrogenase (LDH) interferes with the test. Affected lot numbers are listed in specific ranges for each catalog number.

Certain lots of Beckman Coulter Access 2 Reaction Vessels contain small defects on the bottom that may cause errors in laboratory immunoassay instruments. These defects could delay patient test results. The recall affects specific lot numbers distributed nationwide and globally.

Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.

Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.

An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.