PlainRecalls

Beckman Coulter Inc.

Compiled from official public sources by the editorial team.

330 recalls on record · Latest: Apr 29, 2026

Beckman Coulter Inc. Recall Insight

Beckman Coulter Inc. appears on 330 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.324% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 29, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 48 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Mar 9, 2022 to Jan 1, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 hu…

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 …

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 s…

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…

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 a…

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-stimulatin…

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 qua…

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 instrume…

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 …

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 dev…

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) 7…

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-v…

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 Imm…

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

FDA Devices Low Apr 27, 2022

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

FDA Devices Moderate Mar 9, 2022

AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.