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

View all 241 device recalls →

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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