Beckman Coulter, Inc. recalls
Every recall we track for Beckman Coulter, Inc. — 199 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Beckman Coulter, Inc. peaked in 2025 (45); 199 since 2017. 1% rated “stop using now”.
All FDA recall records for Beckman Coulter, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 16 | 0 | 16 |
| 2018 | 0 | 0 | 28 | 0 | 28 |
| 2019 | 0 | 1 | 29 | 0 | 30 |
| 2020 | 2 | 0 | 7 | 0 | 9 |
| 2021 | 0 | 2 | 12 | 1 | 15 |
| 2022 | 0 | 0 | 3 | 0 | 3 |
| 2023 | 0 | 0 | 20 | 1 | 21 |
| 2024 | 0 | 6 | 17 | 0 | 23 |
| 2025 | 0 | 2 | 43 | 0 | 45 |
| 2026 (to date) | 0 | 2 | 5 | 2 | 9 |
What to do if you have a recalled Beckman Coulter, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Beckman Coulter, Inc. recalls
60 shown- Lower riskMedical device
Beckman Coulter Inc. recalls DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC
Beckman Coulter recalls DxC 500i Clinical Analyzer Modules with specific part numbers due to a software issue that can cause test results to show falsely elevated values when plasma samples are tested.
Beckman CoulterSep 2, 2026 - Use cautionMedical device
Beckman Coulter, Inc. recalls DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Beckman Coulter recalls 2,088 DxU 840m Iris and DxU 850m Iris devices due to risk of lamina fluid leakage from a check valve not replaced annually. This may cause slips, chemical exposure, biohazards, or delayed patient results.
Beckman CoulterAug 12, 2026 - Lower riskMedical device
Beckman Coulter Inc. recalls Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC
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 CoulterJul 15, 2026 - Lower riskMedical device
Beckman Coulter Inc. recalls REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: -
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 CoulterJun 26, 2026 - Use cautionMedical device
Beckman Coulter, Inc. recalls Access Total T4 Calibrator, Catalog No. 33805
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 CoulterMar 16, 2026 - Lower riskMedical device
Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603, with software
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 CoulterDec 23, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
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 CoulterNov 26, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in
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 CoulterNov 10, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and
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 CoulterNov 7, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
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 CoulterOct 1, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use
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 CoulterSep 22, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Part Number C11137
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 CoulterSep 19, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
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 CoulterSep 17, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan
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 CoulterSep 8, 2025 - Use cautionMedical device
Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use
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 CoulterSep 8, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
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 CoulterSep 3, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
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 CoulterAug 13, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part
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 CoulterAug 4, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining
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 CoulterJul 24, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
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 Coul: Inc.Jul 10, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter recalls UIBC assay kits that may not meet claimed hemoglobin interference specifications, potentially causing inaccurate results in low UIBC samples.
Beckman Coul: Inc.Jun 26, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls MicroScan Neg MIC 3J REF C54814
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 Coul: Inc.Jun 25, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
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 CoulterJun 25, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and
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 CoulterJun 12, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137
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 CoulterMay 7, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access Testosterone assay, Catalog Number 33560
Beckman Coulter recalls Access Testosterone assay (Catalog 33560) due to cross-contamination risk from inadequate maintenance, potentially causing inaccurate patient results.
Beckman Coul: Inc.May 5, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
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 CoulterApr 23, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
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 CoulterApr 23, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164;
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 CoulterApr 8, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer
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 CoulterMar 27, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The
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 CoulterMar 20, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065
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 CoulterMar 17, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
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 CoulterFeb 27, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The
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 CoulterFeb 26, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
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 CoulterFeb 6, 2025 - Use cautionMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, 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 CoulterFeb 5, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access 2 Immunoassay Analyzer, Catalog Number 81600N
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 CoulterFeb 5, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney,
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 CoulterFeb 3, 2025 - Lower riskMedical device
Beckman Coulter Inc. recalls Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
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 Coul: A short, human brand name for headings (e.g.Jan 2, 2025 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of
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 CoulterNov 26, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac
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 CoulterNov 18, 2024 - Use cautionMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
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 CoulterNov 13, 2024 - Lower riskMedical device
Beckman Coulter Inc. recalls Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative
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 CoulterNov 8, 2024 - Use cautionMedical device
Beckman Coulter, Inc. recalls The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination
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 CoulterSep 30, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The
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 CoulterSep 5, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative
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 CoulterAug 28, 2024 - Lower riskMedical device
Beckman Coulter Inc. recalls IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with
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 Coul: Inc.Jul 31, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro
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 CoulterJul 16, 2024 - Use cautionMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative,
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.
Beckman CoulterJul 12, 2024 - Use cautionMedical device
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with undersized pneumatic tubing that may cause air leaks and sample processing errors. Four complaints led to this recall.
Beckman CoulterJul 10, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter recalls Access 2 Immunoassay System Analyzers with misaligned index wheels that cause reagent errors and delayed patient results.
Beckman CoulterJun 14, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter recalls Dxl 9000 Access Immunoassay Analyzers with nonconforming USB cables that may corrode over time, causing delayed patient results. Affected units have specific serial numbers and catalog numbers.
Beckman CoulterJun 4, 2024 - Lower riskMedical device
Beckman Coulter Inc. recalls Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Beckman Coulter recalls specific IGM 4x14 mL R1 and 4x11 mL R2 test kits due to incorrect lipemia settings that may cause patient samples to show false low results or normal results for high results.
Beckman CoulterMay 27, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.17 and below that may cause delayed patient test results due to error messages when connected to lab systems.
Beckman CoulterMay 22, 2024 - Use cautionMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.17.0 or below due to sample timeout errors that may delay patient treatment. Affected units have specific catalog numbers and UDI-DI codes.
Beckman CoulterMay 22, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the
Beckman Coulter recalls Dxl 9000 Access Immunoassay Analyzers with software version 1.16.2 or older that may report inaccurate patient results due to expired calibration materials.
Beckman CoulterApr 18, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers due to calibration errors that could lead to incorrect test results. Affected units include specific serial numbers and models. No immediate action is required but users should verify their device and contact the manufacturer for guidance.
Beckman CoulterApr 18, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with cracks in the wash buffer tank that may leak, causing test delays and exposure risks. Affected units have specific serial numbers.
Beckman CoulterMar 5, 2024 - Use cautionMedical device
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer due to pneumatic tubing disconnecting during use, potentially causing false test results and delayed critical treatments like troponin tests.
Beckman CoulterFeb 29, 2024 - Lower riskMedical device
Beckman Coulter, Inc. recalls Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Beckman Coulter recalls four lots of Access Total T4 reagent (lots 338555-338958) due to possible imprecision causing inaccurate thyroid test results. Affected units expire by October 2024.
Beckman CoulterFeb 8, 2024
Beckman Coulter, Inc. recall questions
How many recalls has Beckman Coulter, Inc. had?
199 recalls from Beckman Coulter, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Beckman Coulter, Inc. recall?
Beckman Coulter Inc. recalls DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC, dated Sep 2, 2026. Every Beckman Coulter, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Beckman Coulter, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Beckman Coulter, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.