Beckman Coulter recalls

Beckman Coulter appears in 334 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal fa…
  FDA Device · Class II · 2025-03-12 · Beckman Coulter
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137
  FDA Device · Class II · 2025-02-12 · Beckman Coulter
• Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
  FDA Device · Class II · 2025-02-12 · Beckman Coulter
• Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hor…
  FDA Device · Class II · 2025-01-15 · Beckman Coulter
• Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit
  FDA Device · Class II · 2025-01-01 · Beckman Coulter
• Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact pa…
  FDA Device · Class II · 2024-12-18 · Beckman Coulter
• The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in…
  FDA Device · Class II · 2024-11-13 · Beckman Coulter
• Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168
  FDA Device · Class II · 2024-11-06 · Beckman Coulter
• The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-…
  FDA Device · Class II · 2024-10-23 · Beckman Coulter
• Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device
  FDA Device · Class III · 2024-10-23 · Beckman Coulter
• IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Sy…
  FDA Device · Class II · 2024-10-23 · Beckman Coulter
• Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137
  FDA Device · Class II · 2024-10-16 · Beckman Coulter
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137
  FDA Device · Class II · 2024-09-25 · Beckman Coulter
• DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative dete…
  FDA Device · Class II · 2024-09-11 · Beckman Coulter
• DxI 9000 Access Immunoassay Analyzer, Catalog #C11137
  FDA Device · Class II · 2024-09-04 · Beckman Coulter
• Discrete photometric chemistry analyzer for clinical use
  FDA Device · Class II · 2024-08-21 · Beckman Coulter
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137
  FDA Device · Class II · 2024-08-21 · Beckman Coulter
• Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137
  FDA Device · Class II · 2024-07-31 · Beckman Coulter
• Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
  FDA Device · Class II · 2024-07-31 · Beckman Coulter
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use
  FDA Device · Class II · 2024-07-10 · Beckman Coulter
• DxI 9000 Access Immunoassay Analyzer, C11137
  FDA Device · Class II · 2024-07-10 · Beckman Coulter
• Access Substrate, REF 81906, For use with the Access Immunoassay Systems
  FDA Device · Class II · 2024-04-03 · Beckman Coulter
• Access Total T4, REF 33800, IVD, thyroxine reagent assay
  FDA Device · Class II · 2024-03-27 · Beckman Coulter
• Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
  FDA Device · Class II · 2024-02-14 · Beckman Coulter
• DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior
  FDA Device · Class II · 2024-02-14 · Beckman Coulter
• 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) 700-3…
  FDA Device · Class II · 2024-01-31 · Beckman Coulter
• iQ Waste Well Adapter, Part Number: 700-3393
  FDA Device · Class II · 2024-01-31 · Beckman Coulter
• REV 2 Flowcell Capsule Spare, Part Number: C04154
  FDA Device · Class II · 2024-01-31 · Beckman Coulter
• Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
  FDA Device · Class II · 2024-01-31 · Beckman Coulter
• Access Thyroglobulin Calibrators
  FDA Device · Class II · 2023-10-18 · Beckman Coulter
• DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below
  FDA Device · Class II · 2023-10-18 · Beckman Coulter
• Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
  FDA Device · Class II · 2023-09-06 · Beckman Coulter
• Ringed DxI Reaction Vessels (RVs)
  FDA Device · Class II · 2023-08-02 · Beckman Coulter
• COULTER DxH Diluent, REF 628017
  FDA Device · Class II · 2023-07-19 · Beckman Coulter
• Access Hybritech p2PSA reagent, REF B03704 and REF A49752
  FDA Device · Class II · 2023-07-05 · Beckman Coulter
• Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
  FDA Device · Class II · 2023-05-24 · Beckman Coulter
• Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
  FDA Device · Class II · 2023-05-24 · Beckman Coulter
• Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
  FDA Device · Class II · 2023-05-24 · Beckman Coulter
• UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
  FDA Device · Class II · 2023-05-24 · Beckman Coulter
• DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
  FDA Device · Class II · 2023-05-24 · Beckman Coulter
• iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345
  FDA Device · Class II · 2023-05-24 · Beckman Coulter
• DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
  FDA Device · Class II · 2023-05-24 · Beckman Coulter
• Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs
  FDA Device · Class II · 2023-04-26 · Beckman Coulter
• Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N)
  FDA Device · Class II · 2023-03-22 · Beckman Coulter
• BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only
  FDA Device · Class II · 2023-01-11 · Beckman Coulter
• MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
  FDA Device · Class II · 2022-11-30 · Beckman Coulter
• DxM 1040 MicroScan WalkAway Instrument REF B1018-440
  FDA Device · Class II · 2022-05-25 · Beckman Coulter
• MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
  FDA Device · Class II · 2022-05-25 · Beckman Coulter
• MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
  FDA Device · Class II · 2022-05-25 · Beckman Coulter
• MicroScan WalkAway-96 plus Instrument REF B1018-284
  FDA Device · Class II · 2022-05-25 · Beckman Coulter