Every recall we track for Beckman Coulter, Inc. — 195 in all — plus the complaints and injury reports the public filed about them.
Beckman Coulter recalls DxC 500i Clinical Analyzer Modules with software version 1.5 or lower that may generate incorrect patient test results when importing new Parameter Packages.
Beckman Coulter recalls DxC 500 AU Clinical Analyzer Modules with software version 1.5 or lower that may generate incorrect patient test results after importing new parameter packages.
Beckman Coulter recalls MicroScan LabPro V5.03 Panel Update 11 (US) electronic updates that may cause false antimicrobial susceptibility test results. Affected instruments include MicroScan autoSCAN-4, WalkAway-40 plus, WalkAway-96 plus, and DxM-1040/DxM-1096 models.
Beckman Coulter recalls MicroScan LabPro V5.03 Panel Update 11 DVD Kit for incorrect algorithms that may cause false antimicrobial susceptibility test results. Affected instruments include B1018-280 to B1018-496 models.
Beckman Coulter recalls Access Total T4 Calibrator (Catalog No. 33805) with negative bias causing false low patient results. This may lead to unnecessary tests, delayed hyperthyroidism treatment, or incorrect dosing for pregnant patients.
Beckman Coulter recalls CellMek SPS Sample Preparation System with software error causing sample loss and potential incorrect diagnosis. Affected units have specific model and software version.
Beckman Coulter recalls UniCel Dxl 800 analyzers with specific part numbers that may not restart after shutdown, causing delayed patient test results.
Beckman Coulter recalls UniCel Dxl 600 analyzers with specific part numbers that may not restart after shutdown, leading to delayed patient test results. Affected units require immediate action to prevent incomplete testing.
Beckman Coulter recalls specific lots of DxH Diluent (REF 628017 and C67250) that may cause elevated platelet counts in blood tests. Affected units include certain lot numbers for use with UniCel DxH analyzers.
Beckman Coulter recalls certain Access 2 Reaction Vessels with possible manufacturing deformities that could cause instrument errors and delay patient results. Affected lots include P243943 through P250005.
Beckman Coulter recalls 100+ UniCel DxI 800 photometric analyzers with specific part numbers and serials due to potential z-axis movement errors causing delays in test results.
Beckman Coulter recalls UniCel DxI 600 photometric analyzers with specific part numbers and serials due to potential z-axis movement errors causing delays in test results.
Beckman Coulter recalls DxFLEX Flow Cytometers with specific serial numbers due to a software error that may cause delayed patient results when running custom acquisition protocols.
Beckman Coulter recalls DxC 500i Clinical Analyzer Modules due to software issue causing false patient results if samples are retested with same ID number.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer with software anomaly that may cause false low/high patient results if manual dilution factors aren't applied correctly. Affected units have specific serial numbers.
Beckman Coulter recalls SYNCHRON Systems Direct LDL Cholesterol reagent lot M404166 due to potential false high cholesterol results. Affected units may need replacement to ensure accurate blood tests.
Beckman Coulter recalls MicroScan Neg Multidrug Resistant MIC 1 REF C32368 with UDI-DI code 15099590720568 due to incorrect processing in multidrug resistant testing. This may affect lab results for gram-negative bacteria.
Beckman Coulter recalls CellMek SPS Sample Preparation System software versions 2.2.122.0 and prior with incorrect dead volumes that may lead to incorrect diagnosis or treatment errors.
Beckman Coulter recalls specific SYNCHRON Systems Phosphorus reagent lots that may fail calibration before expiration, causing delays in patient test results. Affected lots include M309642, M309641, etc. Contact for remedy.
Beckman Coulter recalls UniCel DxH 600 analyzers with HGB photometers that may give falsely high hemoglobin readings when samples have high white blood cell counts. Affected units have specific serial numbers and reference codes.
Beckman Coulter recalls UniCel DxH 690T analyzers with HGB photometers that may give falsely high hemoglobin readings on samples with high white blood cell counts. Affected units have specific serial numbers and reference codes.
Beckman Coulter recalls UniCel DxH 900 analyzers with HGB photometers that may give falsely high hemoglobin results when samples have elevated white blood cell counts. Affected units have specific serial numbers and reference codes.
Beckman Coulter recalls UniCel DxH 800 hematology analyzers configured with HGB photometers that may give falsely high hemoglobin results when samples have elevated white blood cell counts. Affected units include specific model references and serial numbers.
Beckman Coulter recalls DxC 500 AU Module with ISE and without ISE for potential processing delays when ordering clinical chemistry and immunoassay tests together. Affected units may show incorrect status during testing.
Beckman Coulter recalls MicroScan Neg MIC 56 REF C42464 panels due to potential contamination in wells. Affected units have UDI-DI code 15099590731212. Contact for remedy details.
Beckman Coulter recalls Access Thyroglobulin reagent lot 439163 that may produce falsely high patient results, potentially leading to unnecessary imaging or therapy adjustments for thyroid cancer monitoring.
Beckman Coulter recalls UIBC assay kits that may not meet claimed hemoglobin interference specifications, potentially causing inaccurate results in low UIBC samples.
Beckman Coulter recalls UniCel DxI 800 Access Immunoassay Analyzers with linear slide PSL software version 1.0.0.1 or earlier. These units may have incorrect motor settings that cause test delays. Affected units have serial numbers starting with 610... or 630...
Beckman Coulter recalls UniCel DxI 600 Access Immunoassay Analyzers with specific software versions due to potential motion errors that could delay patient test results. Affected units have unique serial numbers listed in the recall.
Beckman Coulter recalls DxI 600 Access Immunoassay Analyzers with specific serial numbers due to incorrect motor current settings that could delay patient test results. Affected units may require software updates to prevent reporting errors.
Beckman Coulter recalls MicroScan Neg MIC 3J REF C54814 due to missing drug in well 4 but containing double antibiotics. Affected units sold in 2025 with lot number 2025-08-23.
Beckman Coulter recalls DxI 800 Access Immunoassay Analyzers with specific serial numbers due to software issues causing potential delays in patient test results.
Beckman Coulter recalls DxI 600 Access Immunoassay Analyzers with specific serial numbers due to software issues causing potential delays in patient test results. Affected units may require correction to prevent reporting errors.
Beckman Coulter recalls DxI 800 Access Immunoassay Analyzers with specific serial numbers due to incorrect motor settings that could delay patient test results. Affected units may require correction to prevent reporting errors.
Beckman Coulter recalls Estrone RIA kits with specific lots due to false high estrone results from BSA issues. Affected kits may give inaccurate test results.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer C11137 with calibration issues that may cause incorrect test results and delays. Affected units have specific serial numbers.
Beckman Coulter recalls Access Testosterone assay (Catalog 33560) due to cross-contamination risk from inadequate maintenance, potentially causing inaccurate patient results.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software version 1.20 that may cause assay errors and delayed results due to incorrect motor/encoder installation.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer with software version 1.20 due to error codes preventing assay results. Affected units may require field service.
Beckman Coulter recalls REMISOL Advance units with specific UDI-DI codes and software versions due to a software defect that may incorrectly identify newborn patients, affecting validation rules and reference ranges.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.20.0 or older that may lose connection to lab systems, delaying patient test results and treatment.
Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific catalog numbers due to a software error that prevents calibration orders from completing, potentially delaying test results.
Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific catalog numbers and software versions due to incorrect sample barcode identification causing erroneous test results.
Beckman Coulter recalls Access Vitamin B12 Reagent lot 439850 due to potential erroneous Vitamin B12 results, which could lead to delayed or improper diagnosis. Affected units may need replacement.
Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific software versions due to a defect that may cause delays in reporting patient test results when recalculating results.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with specific firmware versions that may cause delays in patient result reporting. Affected units include those with PCB, TSI/RSI firmware C29278 and catalog number C11137.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with misaligned encoder wheels that may cause instrument stoppages and delays in patient results.
Beckman Coulter recalls Access 2 Immunoassay Analyzers with specific serial numbers due to a motor alignment issue that could delay patient test results. Affected units have a worn production tool causing sample motor misalignment.
Beckman Coulter recalls Access Erythropoietin (EPO) lot 439363 due to potential false low results in patient tests, which could lead to improper diagnosis. Affected units may need replacement.
Beckman Coulter recalls Access PCT Reagent Pack (Catalog C53987) for calibration failures on Access 2 and UniCel Dxl systems, potentially delaying lab results. Affected lots 339062 and 439811.
Beckman Coulter recalls Access Intact PTH assay reagent packs from lot 339071 that may be over- or under-filled, risking inaccurate test results. Affected units were identified through internal testing on April 10, 2024.
Beckman Coulter recalls Access hsTnI reagent (REF B52699) due to risk of false high troponin results affecting patient care. Contamination may cause unnecessary cardiac imaging or procedures.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with specific serial numbers due to potential wash wheel mixer malfunction causing test delays and system errors.
Beckman Coulter recalls Access Intact PTH assay for DxI 9000 analyzer due to false low parathyroid hormone results from prolonged sample storage. This may cause missed diagnoses or delayed treatment.
Beckman Coulter recalls Access Cortisol assay kits due to potential calibration failures from incorrect calibration curve parameters, which may delay results and cause injuries. Affected units include all lots with UDI/DI 15099590231118.
Beckman Coulter recalls Access Thyroglobulin Antibody II (TgAb) assays with incorrect instructions that may cause false-low results. Affected units shipped from July 2021 to current. Contact for remedy.
Beckman Coulter recalls specific lots of Access TSH reagent packs that may produce erroneously low thyroid-stimulating hormone results. Affected lots include 339117, 338724, 439341, 338367, 338057, 234251.
Beckman Coulter recalls IGM Immunoglobulin M Reagent REF 447610 due to sensitivity problems in immunochemistry tests. Affected lots M307362 and M309410 may not meet required sensitivity levels.
Beckman Coulter recalls IRISPEC CA/CB/CC Urine Chemistry Controls (REF 800-7211/7702) due to intermittent glucose control failures causing false positives with iChemVELOCITY strips. This may delay diagnosis of metabolic disorders and kidney issues.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with catalog number C11137 due to ground screw issues causing electric shorts, smoke, and delayed patient results.
