Beckman Coulter Inc.
Complete recall history across all FDA and CPSC categories — 241 total recalls
Beckman Coulter Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (241)
FDA medical device enforcement actions by Beckman Coulter Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 22, 2025 | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 T... | Due to a software error code that crashes during acquisition on patient sampl... | Class II |
| Sep 17, 2025 | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 | Beckman Coulter has identified that there is an increased probability Synchro... | Class II |
| Sep 3, 2025 | SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagno... | Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) rea... | Class II |
| Aug 13, 2025 | UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB ... | Hematology analyzers configured with HGB photometers may result in erroneousl... | Class II |
| Aug 13, 2025 | UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB... | Hematology analyzers configured with HGB photometers may result in erroneousl... | Class II |
| Aug 13, 2025 | UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB ... | Hematology analyzers configured with HGB photometers may result in erroneousl... | Class II |
| Aug 13, 2025 | UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB ... | Hematology analyzers configured with HGB photometers may result in erroneousl... | Class II |
| Aug 4, 2025 | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Modul... | On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination t... | Class II |
| Jun 26, 2025 | UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, | Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) ... | Class II |
| Jun 12, 2025 | Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative m... | A specific lot of bovine serum albumin (BSA) used for manufacturing of coated... | Class II |
| Apr 8, 2025 | REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487;... | Due to a software issue, the software may incorrectly process the date of bir... | Class II |
| Mar 20, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer bec... | Class II |
| Mar 17, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | The reason for the recall is incorrect sample barcode identification and proc... | Class II |
| Feb 26, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4... | Class II |
| Jan 2, 2025 | Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and Uni... | Identified reagent lots are experiencing a high rate of calibration failures ... | Class II |
| Nov 8, 2024 | Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog ... | The reason for the recall is that EDTA and lithium heparin plasma samples tha... | Class II |
| Jul 31, 2024 | IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM... | Firm identified two lots of reagents that are not meeting the sensitivity sta... | Class II |
| May 27, 2024 | Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 | LIH Influence check settings for Lipemia are incorrect which may result patie... | Class II |
| Jul 12, 2023 | Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 | Lipemic interference failed to meet the performance specification listed with... | Class II |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagen... | Class II |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagen... | Class II |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagen... | Class II |
| Dec 8, 2021 | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 | Lipemic interference for the Magnesium serum application failed to meet the p... | Class II |
| Nov 10, 2021 | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 | Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/... | Class II |
| Aug 9, 2021 | Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay Sy... | Through customer feedback, testing a sample with cardiac troponin I concentra... | Class II |
| Aug 5, 2021 | Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT P... | Firm's submission for Emergency Use Authorization (EUA) contained insufficien... | Class II |
| Jul 28, 2021 | Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockya... | Missing splash guard which may expose users to hazardous materials. . | Class II |
| Jul 21, 2021 | DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use"... | There is a potential that sample carriers (w or w/o samples) within automated... | Class II |
| Jul 15, 2021 | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017... | There is a potential that the data management system may add additional cells... | Class II |
| Jul 1, 2021 | Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.... | SARS-CoV-2 Antigen Assay test may generate false positive results which could... | Class II |
| Jul 1, 2021 | ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; | SARS-CoV-2 Antigen Assay test may generate false positive results which could... | Class II |
| Jul 1, 2021 | ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTIO... | SARS-CoV-2 Antigen Assay test may generate false positive results which could... | Class II |
| Jul 1, 2021 | ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 ... | SARS-CoV-2 Antigen Assay test may generate false positive results which could... | Class II |
| May 7, 2021 | Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a fact... | Class II |
| May 7, 2021 | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a fact... | Class II |
| Apr 14, 2021 | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, ... | specimens collected in transport media may result is false negative results w... | Class II |
| Dec 30, 2020 | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on th... | The Quality Control (QC) card has a label error for the standard deviation (S... | Class II |
| Dec 2, 2020 | MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of ant... | Due to a customer report and internal investigation, it was confirmed that a ... | Class II |
| Aug 26, 2020 | BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF... | Due to alkaline phosphatase (ALP) associated interference causing falsely ele... | Class II |
| Aug 18, 2020 | UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNIN... | The manufacturer has identified that the use of Unsaturated Iron Binding Capa... | Class II |
| Mar 30, 2020 | iQ200 Series Urine Microscopy Analyzer- All part numbers | A defect in the SATA power adapter cable within the instrument s computer has... | Class II |
| Mar 30, 2020 | iChem¿VELOCITY Urine Chemistry System- | A defect in the SATA power adapter cable within the instruments computer has ... | Class II |
| Jan 29, 2020 | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 -... | Electrolyte reference reagent, used for clinical laboratory testing to determ... | Class II |
| Jan 17, 2020 | LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPr... | A security-only update was released via remote diagnostics on January 14, 202... | Class II |
| Dec 13, 2019 | Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-1... | Due to customer reports it has been determined that the inoculation system c... | Class II |
| Nov 7, 2019 | iChem VELOCITY Urine Chemistry Analyzer | Beckman Coulter has become aware of an issue affecting Specific Gravity chemi... | Class II |
| Oct 28, 2019 | iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375,... | Customers have reported incidents where two sets of results report the same S... | Class II |
| Oct 28, 2019 | iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-71... | Customers have reported incidents where two sets of results report the same S... | Class II |
| Oct 21, 2019 | MicroScan WalkAway-96 plus Instrument REF B1018-284 | WalkAway Instruments may have been assembled with the incorrect AC power entr... | Class II |
| Oct 21, 2019 | MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R | WalkAway Instruments may have been assembled with the incorrect AC power entr... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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