Beckman Coulter, Inc. recalls

Beckman Coulter has recalled certain SW40 rotors (Reference 331302) used in Optima XE and XPN ultracentrifuges due to a defect that can cause rotors to break during operation. Rotor breakage destroys samples being processed and can expose laboratory workers to biohazardous materials. When used for patient testing, breakage may delay diagnostic results.

Moderate·FDA·Oct 21, 20262 products

Beckman Coulter is recalling DxU 840m and 850m Iris analyzers and several IQ200 Sprint, Select, and Elite analyzer models. The rinse-line check valve on these instruments wears out sooner than expected and needs yearly replacement, but that step was left out of the required preventive maintenance schedule. If the valve is not replaced, lamina fluid can leak onto the table or floor, and no injuries have been reported.

Moderate·FDA·Oct 21, 20262 products

Beckman Coulter identified a software issue in its DxC 500i and DxC 500 AU Clinical Chemistry Analyzers used for testing plasma samples. After a user changes a test to non-default units and later activates a configuration change, the analyzer may revert to the default units without warning, which can lead to falsely elevated reported results. The recall covers 2 product groups with 6 modules and analyzers in total.

Moderate·FDA·Oct 14, 20262 products

Certain Beckman Coulter AU480 Chemistry Analyzers may fail to start due to a software error when the system boots. When this happens, the instrument cannot begin processing patient samples, which delays test results. This affects approximately 492 units distributed worldwide.

Moderate·FDA·Oct 7, 2026

Beckman Coulter is recalling two products, DxC 500i and DxC 500 AU clinical analyzer modules, when they run software version 1.5 or lower. When a new Parameter Package is imported into an instrument that already has one, custom calculated test rules can silently revert to default settings, which may produce incorrect patient test results without an error message. New installations are not affected, and no injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

Beckman Coulter is recalling the MicroScan LabPro V5.03 Panel Update 11 DVD kit used on certain MicroScan analyzers. The software algorithms may produce incorrect antimicrobial susceptibility results, which could lead to bacteria being labeled as susceptible or resistant to a drug when they are not.

Moderate·FDA·Aug 12, 2026

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

FDA·Apr 15, 2026

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.

Moderate·FDA·Apr 15, 2026

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.

Moderate·FDA·Apr 1, 2026

Beckman Coulter is recalling two clinical chemistry analyzer models, the DxC 700 AU and the AU5800, because the calibration monitor PC can show database errors if it is left open for more than 15 minutes. When this happens, the system can stop analyzing samples, which may delay test results, diagnosis, or patient treatment. No injuries have been reported.

Moderate·FDA·Mar 18, 20262 products

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.

Moderate·FDA·Feb 11, 2026

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.

Moderate·FDA·Feb 11, 2026

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.

Moderate·FDA·Jan 28, 2026

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.

Moderate·FDA·Jan 14, 20262 products

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.

Moderate·FDA·Dec 31, 2025

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.

Moderate·FDA·Dec 17, 2025

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.

FDA·Nov 26, 2025

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.

FDA·Nov 12, 2025

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.

FDA·Nov 12, 20252 products