Manufacturer
71 recalls in our database name Beckman Coulter, Inc. as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.
Beckman Coulter is recalling MicroScan Neg Multidrug Resistant test kits due to incorrect manufacturing processing of the in vitro antimicrobial test. The defect may affect diagnostic accuracy.
Beckman Coulter is recalling MicroScan Neg MIC 3J diagnostic panels due to manufacturing errors affecting test accuracy. One well per panel is missing a required drug while others contain double the intended amount of antibiotics.
Beckman Coulter is recalling 685 boxes of MicroScan Neg MIC 56 diagnostic panels due to likely presence of contamination in test wells. The affected lot was distributed across 12 U.S. states.
A software error in the CellMek SPS Sample Preparation System causes samples to be dispensed incorrectly, resulting in sample loss of 60-100 microliters. This could lead to incorrect laboratory results and patient management decisions.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to elevated background counts in platelet Daily Checks when used with UniCel DxH analyzers. This can affect test result accuracy.
Beckman Coulter's UniCel DxL 600 analyzer may fail to restart after shutdown due to a communication issue, preventing sample processing and causing delayed results. 1,272 units recalled worldwide.
Beckman Coulter UniCel Dxl 800 analyzers may fail to restart following standard shutdown due to a communication issue. When this occurs, units cannot process patient samples, resulting in delayed test results.
Beckman Coulter is recalling 38,225 Access 2 Reaction Vessels that may have manufacturing deformities causing instrument errors and delays in patient test results.
Beckman Coulter UniCel DxI 600 lab analyzers are recalled due to defective gantry components that may cause the device to malfunction and delay test results. No illnesses have been reported.
Beckman Coulter is recalling 657 UniCel DxI 800 chemistry analyzers worldwide due to defective gantry sub-components that may cause a z-axis motion error, making the analyzer pause or become unready and delaying test results.
Beckman Coulter's CellMek SPS Sample Preparation System has incorrect dead volume specifications in its instructions and a software defect affecting specimen processing. The errors may lead to incorrect diagnoses or errors in patient management.
Beckman Coulter clinical laboratory analyzers have a software defect that may prevent correct application of dilution factors to patient samples, potentially producing false test results and diagnostic errors.
Beckman Coulter DxI 9000 Access Immunoassay Analyzers have a software anomaly that may prevent correct application of manual dilution factors, potentially resulting in false high or low patient test results.
Beckman Coulter's Access Thyroglobulin assay lot 439163 may produce falsely elevated results, potentially leading to unnecessary diagnostic imaging and inappropriate therapy adjustments in thyroid cancer patients.
Beckman Coulter DxI 800 analyzers may have incorrect motor current settings that reset during software updates, potentially delaying patient sample result reporting.
Beckman Coulter's DxI 800 immunoassay analyzers with certain software versions have a motor current setting that incorrectly resets during updates, potentially delaying patient test result reporting.
Beckman Coulter's DxI 600 Access Immunoassay Analyzer has a software defect causing incorrect motor current settings that may delay patient sample result reporting. The issue affects systems running software versions 5.7 and later.
Beckman Coulter's UniCel DxI 800 analyzer has a software defect causing the motor current to reset to 1.5A instead of 2.0A during updates, potentially delaying patient sample reporting. Affected devices require remediation.
Beckman Coulter is recalling 271 UniCel DxI 600/800 analyzers with incorrect motor current settings due to a software issue that could delay patient sample reporting.
Beckman Coulter's DxI 600 Access Immunoassay Analyzer has a software issue causing incorrect motor current settings that lead to motion errors and potential delays in patient sample reporting. The recall affects 177 systems worldwide.
Beckman Coulter's Access Vitamin B12 Reagent lot 439850 may produce falsely low or high results, potentially causing misdiagnosis or unnecessary repeat testing.
DxI 9000 immunoassay analyzer may produce calibration failures where curves incorrectly switch from passed to failed, resulting in erroneous test results. Results may be misinterpreted by laboratory information systems.
Beckman Coulter is recalling 324 units of the DxI 9000 Access Immunoassay Analyzer due to incorrect motor and cable installation that causes error codes, preventing test performance and delaying results.
Beckman Coulter's Access Testosterone assay (Lot 538081) may produce inaccurate results due to cross-contamination from inadequate maintenance of the fill line. Results could be up to 34% higher or 23% lower than actual values.