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
- Windstone Med…
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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 Feb 12, 2025
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
FDA Devices Moderate Jan 15, 2025
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
FDA Devices Moderate Jan 1, 2025
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
FDA Devices Moderate Dec 18, 2024
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
FDA Devices Moderate Nov 13, 2024
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
FDA Devices Moderate Nov 6, 2024
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
FDA Devices Moderate Oct 23, 2024
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
FDA Devices Low Oct 23, 2024
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
FDA Devices Moderate Oct 23, 2024
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer i
FDA Devices Moderate Oct 16, 2024
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. 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 Sep 25, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
FDA Devices Moderate Sep 11, 2024
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
FDA Devices Moderate Sep 4, 2024
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
FDA Devices Moderate Aug 21, 2024
Discrete photometric chemistry analyzer for clinical use.
FDA Devices Moderate Aug 21, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
FDA Devices Moderate Jul 31, 2024
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
FDA Devices Moderate Jul 31, 2024
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
FDA Devices Moderate Jul 10, 2024
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
FDA Devices Moderate Jul 10, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
FDA Devices Moderate Apr 3, 2024
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
FDA Devices Moderate Mar 27, 2024
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
FDA Devices Moderate Feb 14, 2024
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
FDA Devices Moderate Feb 14, 2024
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
FDA Devices Moderate Jan 31, 2024
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
FDA Devices Moderate Jan 31, 2024
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
FDA Devices Moderate Jan 31, 2024
iQ Waste Well Adapter, Part Number: 700-3393
FDA Devices Moderate Jan 31, 2024
REV 2 Flowcell Capsule Spare, Part Number: C04154
FDA Devices Moderate Oct 18, 2023
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
FDA Devices Moderate Oct 18, 2023
Access Thyroglobulin Calibrators
FDA Devices Moderate Sep 6, 2023
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
FDA Devices Moderate Aug 2, 2023
Ringed DxI Reaction Vessels (RVs)
FDA Devices Moderate Jul 19, 2023
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
FDA Devices Moderate Jul 5, 2023
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
FDA Devices Moderate May 24, 2023
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
FDA Devices Moderate May 24, 2023
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
FDA Devices Moderate May 24, 2023
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
FDA Devices Moderate May 24, 2023
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
FDA Devices Moderate May 24, 2023
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
FDA Devices Moderate May 24, 2023
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
FDA Devices Moderate May 24, 2023
Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
FDA Devices Moderate Apr 26, 2023
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
FDA Devices Moderate Mar 22, 2023
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Devices Moderate Jan 11, 2023
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
FDA Devices Moderate Nov 30, 2022
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
FDA Devices Moderate May 25, 2022
MicroScan WalkAway-40 plus Instrument REF B1018-283
FDA Devices Moderate May 25, 2022
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
FDA Devices Moderate May 25, 2022
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
FDA Devices Moderate May 25, 2022
MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
FDA Devices Moderate May 25, 2022
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
FDA Devices Moderate May 25, 2022
MicroScan WalkAway-96 plus Instrument REF B1018-284
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