Beckman Coulter, Inc.
Miami, FL
This page shows every FDA and USDA recall linked to Beckman Coulter, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
18
Total Recalls
2019
First Recall
2026
Most Recent
CellMek SPS Sample Preparation System, REF: C44603, with software
Feb 2, 2026
· Device
Open, Classified
COULTER DxH Diluent, REF 628017
COULTER DxH ECO Diluent REF C67250
For use as an isotonic buffered diluent in...
Jan 30, 2026
· Device
Open, Classified
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions fo...
Oct 30, 2025
· Device
Open, Classified
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro...
Oct 16, 2024
· Device
Open, Classified
iQ200 Series Urine Microscopy Analyzers, Part Numbers:
a) 700-3320,
b) 700-3370,
c) 700-3345,
d) 700-3347...
Jan 25, 2024
· Device
Open, Classified
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Jan 25, 2024
· Device
Open, Classified
iQ Waste Well Adapter, Part Number: 700-3393
Jan 25, 2024
· Device
Open, Classified
REV 2 Flowcell Capsule Spare, Part Number: C04154
Jan 25, 2024
· Device
Open, Classified
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Jul 12, 2023
· Device
Open, Classified
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
May 17, 2023
· Device
Open, Classified
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite,...
May 17, 2023
· Device
Open, Classified
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
May 17, 2023
· Device
Open, Classified
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
May 17, 2023
· Device
Open, Classified
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic
use only.
Jan 3, 2023
· Device
Open, Classified
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control,...
Feb 16, 2022
· Device
Open, Classified
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2
Kits:
C10574 - Kaluza C Single Perpetual L...
Jun 23, 2021
· Device
Open, Classified
iChemVELOCITY Strips, Catalog 800-7212
Feb 17, 2020
· Device
Terminated
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The...
Oct 7, 2019
· Device
Terminated