PlainRecalls

Beckman Coulter Inc.

222 recalls on record · Latest: Feb 11, 2026

Beckman Coulter Inc. Recall Insight

Beckman Coulter Inc. appears on 222 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.264% 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 Feb 11, 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, 50 moderate, and 0 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 Jul 24, 2019 to Oct 18, 2023.

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 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 Aug 2, 2023

Ringed DxI Reaction Vessels (RVs)

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 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 Dec 29, 2021

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

FDA Devices Moderate Oct 13, 2021

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

FDA Devices Moderate Oct 6, 2021

DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118

FDA Devices Moderate Sep 1, 2021

Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information sys…

FDA Devices Moderate Aug 18, 2021

ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;

FDA Devices Moderate Aug 18, 2021

ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017

FDA Devices Moderate Aug 18, 2021

ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;

FDA Devices Moderate Aug 18, 2021

Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1…

FDA Devices Moderate Jun 30, 2021

Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

FDA Devices Moderate Jun 2, 2021

Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e

FDA Devices Moderate Apr 14, 2021

MicroScan WalkAway-40 plus Instrument

FDA Devices Moderate Apr 14, 2021

MicroScan WalkAway-40 plus Reconditioned Instrument

FDA Devices Moderate Apr 14, 2021

MicroScan WalkAway-96 plus Reconditioned Instrument

FDA Devices Moderate Dec 30, 2020

MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species lev…

FDA Devices Moderate Oct 7, 2020

UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quant…

FDA Devices Moderate Jun 10, 2020

Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Im…

FDA Devices Moderate Jun 10, 2020

Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassa…

FDA Devices Moderate Jun 10, 2020

Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Syste…

FDA Devices Moderate Jun 10, 2020

Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Family of Immu…

FDA Devices Moderate Jun 10, 2020

Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Im…

FDA Devices Moderate Jun 3, 2020

ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbo…

FDA Devices Moderate May 20, 2020

iChem¿VELOCITY Urine Chemistry System-

FDA Devices Moderate May 6, 2020

SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System…

FDA Devices Moderate Apr 29, 2020

Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Sys…

FDA Devices Moderate Apr 15, 2020

LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program a…

FDA Devices Moderate Apr 15, 2020

Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D…

FDA Devices Moderate Apr 1, 2020

iChemVELOCITY Strips, Catalog 800-7212

FDA Devices Moderate Mar 11, 2020

Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228

FDA Devices Moderate Mar 11, 2020

Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733

FDA Devices Moderate Mar 11, 2020

Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281

FDA Devices Moderate Mar 11, 2020

Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnosti…

FDA Devices Moderate Feb 5, 2020

iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry ana…

FDA Devices Moderate Feb 5, 2020

iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-…

FDA Devices Moderate Dec 4, 2019

UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Sl…

FDA Devices Moderate Oct 9, 2019

The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay …

FDA Devices Moderate Jul 24, 2019

Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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