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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318 notices
What this shows Beckman Coulter, Inc. holds about 0.318% of archive notices alongside 332 distinct filings.
FDA Devices Moderate May 31, 2017
Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
FDA Devices Moderate May 31, 2017
UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
FDA Devices Moderate May 31, 2017
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
FDA Devices Moderate May 24, 2017
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.
FDA Devices Moderate May 24, 2017
Access BR Monitor, Part No. 387620
FDA Devices Moderate May 24, 2017
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
FDA Devices Moderate May 24, 2017
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
FDA Devices Moderate May 24, 2017
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
FDA Devices Moderate May 24, 2017
Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma.
FDA Devices Moderate May 24, 2017
Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.
FDA Devices Moderate May 24, 2017
Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
FDA Devices Moderate May 10, 2017
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).
FDA Devices Moderate Apr 26, 2017
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
FDA Devices Moderate Apr 12, 2017
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI 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 12, 2017
UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI 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 12, 2017
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are 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 ion s
FDA Devices Moderate Apr 12, 2017
Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI 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 8, 2017
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used fo
FDA Devices Low Jan 25, 2017
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 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 process. 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 label
FDA Devices Moderate Jan 18, 2017
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
FDA Devices Moderate Jan 18, 2017
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
FDA Devices Moderate Dec 21, 2016
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.
FDA Devices Moderate Nov 30, 2016
AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
FDA Devices Moderate Nov 23, 2016
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
FDA Devices Moderate Nov 23, 2016
Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
FDA Devices Moderate Oct 5, 2016
AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
FDA Devices Moderate Sep 14, 2016
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
FDA Devices Moderate Sep 7, 2016
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC 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
FDA Devices Moderate Aug 10, 2016
AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
FDA Devices Moderate Aug 10, 2016
AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
FDA Devices Moderate Aug 10, 2016
AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
FDA Devices Moderate Aug 3, 2016
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800 Synchron Clinical Systems UniCel DxC 600 Synchron Clinical Systems UniCel DxC 600i Synchron Access Integrated Clinical Systems UniCel DxC 880i Synchron Access Integrated Clin
FDA Devices Moderate Aug 3, 2016
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental s
FDA Devices Moderate Jul 27, 2016
The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.
FDA Devices Moderate Jul 6, 2016
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
FDA Devices Moderate Jun 22, 2016
Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
FDA Devices Moderate Jun 15, 2016
Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.
FDA Devices Moderate Jun 15, 2016
Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.
FDA Devices Moderate Jun 15, 2016
Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.
FDA Devices Moderate Jun 15, 2016
Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.
FDA Devices Moderate Jun 15, 2016
Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
FDA Devices Moderate Apr 6, 2016
MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073 LabPro MBT Connect Systems v4.30 Canada: 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Pan
FDA Devices Moderate Mar 16, 2016
iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001
FDA Devices Moderate Jan 20, 2016
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
FDA Devices Moderate Jan 6, 2016
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Devices Moderate Jan 6, 2016
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Devices Moderate Jan 6, 2016
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Devices Moderate Jan 6, 2016
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Devices Moderate Jan 6, 2016
MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Devices Moderate Dec 23, 2015
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
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