Beckman Coulter recalls

Beckman Coulter has 334 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 26 Aug 2026. 107 are still ongoing. 20 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls334since 2012

Last 12 months20reported

Class I51% of total

Ongoing107latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

2Nov '24 1 2 2Feb 5 3 2May 3 4 8Aug 4 4 5Nov 1 2 2Feb 0 4 0May 0 0 4Aug 0 0

Severity split

Class I 5 1%Class II 314 94%Class III 15 4%

Why beckman coulter is recalled

Product types

By year

2026124%
20254313%
2024247%
2023165%
202293%
2021196%
2020278%
2019124%
2018237%
20173811%

Ongoing beckman coulter recalls

107 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled	Beckman Coulter	Other	Nationwide
12 Aug 2026Device	CLASS II	REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled	Beckman Coulter	Other	Nationwide
29 Apr 2026Device	CLASS II	Access Total T4 Calibrator recalled by Beckman Coulter	Beckman Coulter	Other	Nationwide
15 Apr 2026Device	CLASS II	MicroScan Neg Multidrug Resistant MIC recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	CA

All beckman coulter recalls, newest first

334 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled	Beckman Coulter	Other	Nationwide
12 Aug 2026Device	CLASS II	REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled	Beckman Coulter	Other	Nationwide
29 Apr 2026Device	CLASS II	Access Total T4 Calibrator recalled by Beckman Coulter	Beckman Coulter	Other	Nationwide
15 Apr 2026Device	CLASS II	MicroScan Neg Multidrug Resistant MIC recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	CA
15 Apr 2026Device	CLASS II	MicroScan Neg MIC 3J recalled by Beckman Coulter	Beckman Coulter	Other	CA
1 Apr 2026Device	CLASS II	MicroScan Neg MIC recalled by Beckman Coulter	Beckman Coulter	Other	Nationwide
11 Feb 2026Device	CLASS II	CellMek SPS Sample Preparation System recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	Nationwide
11 Feb 2026Device	CLASS II	Coulter DxH Diluent recalled by Beckman Coulter	Beckman Coulter	Other	Nationwide
14 Jan 2026Device	CLASS II	UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288 recalled	Beckman Coulter	Device Malfunction	Nationwide
14 Jan 2026Device	CLASS II	UniCel Dxl 600, Part numbers: A71460, A71461, A30260 recalled	Beckman Coulter	Device Malfunction	Nationwide
17 Dec 2025Device	CLASS II	Access 2 Reaction Vessels, individual, disposable recalled	Beckman Coulter	Foreign Material	Nationwide
26 Nov 2025Device	CLASS II	DxFLEX Flow Cytometer recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	Nationwide
12 Nov 2025Device	CLASS II	Synchron Systems Direct Ldl Cholesterol (Ldld) Reagent recalled	Beckman Coulter	Other	Nationwide
12 Nov 2025Device	CLASS II	UniCel DxI 800, Part Numbers: 973100, A71456 recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	MN
12 Nov 2025Device	CLASS II	UniCel DxI 600, Part Numbers: A71460, A30260 recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	MN
5 Nov 2025Device	CLASS II	CellMek SPS Sample Preparation System recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	Nationwide
29 Oct 2025Device	CLASS II	DxC 500i Clinical Analyzer Modules recalled by Beckman Coulter	Beckman Coulter	Potency & Assay	Nationwide
29 Oct 2025Device	CLASS II	DxI 9000 Access Immunoassay Analyzer recalled by Beckman Coulter	Beckman Coulter	Potency & Assay	Nationwide
15 Oct 2025Device	CLASS II	Synchron Systems Phosphorus (PHOSm) Reagent recalled by Beckman Coulter	Beckman Coulter	Other	14 states
8 Oct 2025Device	CLASS II	DxC 500 AU Module w/ISE, DxC 500i, With ISE recalled by Beckman Coulter	Beckman Coulter	Potency & Assay	CA
24 Sep 2025Device	CLASS II	UniCel DxH 600 Coulter Cellular Analysis System recalled	Beckman Coulter	Other	Nationwide
24 Sep 2025Device	CLASS II	UniCel DxH 690T Coulter Cellular Analysis System recalled	Beckman Coulter	Other	Nationwide
24 Sep 2025Device	CLASS II	UniCel DxH 900 Coulter Cellular Analysis System recalled	Beckman Coulter	Other	Nationwide
24 Sep 2025Device	CLASS II	UniCel DxH 800 Coulter Cellular Analysis System recalled	Beckman Coulter	Other	Nationwide
20 Aug 2025Device	CLASS II	Access Thyroglobulin assay, a simultaneous one-step recalled	Beckman Coulter	Potency & Assay	Nationwide
13 Aug 2025Device	CLASS II	UniCel DxI 800 Access Immunoassay Analyzer recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	Nationwide
13 Aug 2025Device	CLASS II	UniCel DxI 600 Access Immunoassay Analyzer recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	Nationwide
13 Aug 2025Device	CLASS II	DxI 600 Access Immunoassay Analyzer W/Dual Gantry recalled	Beckman Coulter	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.