Beckman Coulter Inc.
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.
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in hu…
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid …
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human s…
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody…
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems a…
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulatin…
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qua…
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrume…
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination …
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic dev…
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
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…
iQ Waste Well Adapter, Part Number: 700-3393
REV 2 Flowcell Capsule Spare, Part Number: C04154
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Access Thyroglobulin Calibrators
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Ringed DxI Reaction Vessels (RVs)
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
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…
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Imm…
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
MicroScan WalkAway-40 plus Instrument REF B1018-283
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
MicroScan WalkAway-96 plus Instrument REF B1018-284
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.
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Nearby Manufacturers
Other firms with recall activity tracked in the PlainRecalls index.
Data Sources
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.