Beckman Coulter, Inc.
332 recalls on record · Latest: Aug 12, 2026
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Agency notice ledger
Federal filing book Beckman Coulter, Inc. HEAVY-BOOK · SINGLE-AGENCY
#31 of 14,151 · 332 notices · 0.318% archive
- BOOK 332 notices
- RANK #31 of 14,151
- SHARE 0.318% archive
- AGENCY FDA Devices (332)
- CAT medical devices
- CATS 1 category
- LATEST Aug 12, 2026
- PHOTO Windstone Medical Pac…
Nearest notice-volume peer: Windstone Medical Packaging, Inc. (4 notice gap)
Beckman Coulter, Inc. accounts for about 0.318% of the 104,423-notice archive on 332 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Beckman Coulter, Inc.'s standing among 14,151 recalling firms
Beckman Coulter, Inc. ranks 31st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Beckman Coulter, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
332 31st of 14151 higher than 14,120 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Beckman Coulter, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
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340 notices
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338 notices
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336 notices
- Beckman Coult… (this)
Beckman Coulter, Inc.
332 notices
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323 notices
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Whole Foods Market
318 notices
What this shows Beckman Coulter, Inc. holds about 0.318% of archive notices alongside 332 distinct filings.
FDA Devices Moderate May 1, 2013
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.
FDA Devices Moderate Apr 10, 2013
Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Devices Moderate Apr 10, 2013
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Devices Moderate Apr 10, 2013
UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Devices Moderate Apr 10, 2013
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Devices Moderate Mar 27, 2013
Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
FDA Devices Moderate Mar 13, 2013
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
FDA Devices Moderate Jan 2, 2013
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
FDA Devices Moderate Jan 2, 2013
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Syn
FDA Devices Moderate Dec 26, 2012
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
FDA Devices Moderate Nov 28, 2012
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
FDA Devices Moderate Nov 28, 2012
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
FDA Devices Moderate Nov 28, 2012
UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
FDA Devices Moderate Oct 31, 2012
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
FDA Devices Low Oct 31, 2012
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
FDA Devices Moderate Oct 24, 2012
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including the detection of the presence of ad
FDA Devices Moderate Oct 24, 2012
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whol
FDA Devices Moderate Oct 17, 2012
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebr
FDA Devices Moderate Oct 17, 2012
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
FDA Devices Moderate Oct 17, 2012
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
FDA Devices Moderate Oct 17, 2012
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
FDA Devices Moderate Oct 17, 2012
CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
FDA Devices Moderate Oct 17, 2012
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the A
FDA Devices Moderate Oct 17, 2012
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
FDA Devices Moderate Oct 10, 2012
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
FDA Devices Moderate Oct 10, 2012
COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
FDA Devices Low Aug 29, 2012
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.
FDA Devices Moderate Aug 29, 2012
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Devices Moderate Aug 29, 2012
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Devices Moderate Aug 29, 2012
UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker port
FDA Devices Moderate Aug 29, 2012
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker
FDA Devices Moderate Aug 29, 2012
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter, Inc. carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (332 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Beckman Coulter, Inc.? ▼
PlainRecalls indexes 332 distinct federal recall events naming Beckman Coulter, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Beckman Coulter, Inc. sit among other recalling firms? ▼
Beckman Coulter, Inc. ranks #31 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Beckman Coulter, Inc.'s notices? ▼
FDA Devices accounts for 332 of this firm's 332 indexed notices.
What product category dominates Beckman Coulter, Inc.'s filing book? ▼
Filings for Beckman Coulter, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Beckman Coulter, Inc.: 332 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Beckman Coulter, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026