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Beckman Coulter Inc.

Beckman Coulter Inc. Recalls

All product recalls associated with Beckman Coulter Inc..

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Recall Summary

Total Recalls

1000

Past Year

899

Class I (Serious)

125

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 301–320 of 17592 recalls

UniCel DxH 800 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Moderate

FDAAug 13, 2025Nationwide• Beckman Coulter Inc.

Change Healthcare Radiology Software (Change Healthcare) – Report Display Issue (2025)

Due to software issue, radiology reports may not be fully displayed when viewing.

Low

FDAAug 13, 2025Nationwide• CHANGE HEALTHCARE CANADA COMPANY

FLEX Monoclonal Mouse Antibody (Agilent) – weak staining (2025)

Their is the potential for weak staining which may result in false negative CD20 identification.

Moderate

FDA

1...14 151617 18...880

Page 16 of 880Next

Aug 11, 2025

Nationwide

• Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark

Lisdexamfetamine Capsules (Lannett) - Label Mix-up (2025)

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

Class IIModerate

FDAAug 11, 2025Nationwide• Lannett Company Inc.

RayStation Software (RaySearch) – UID uniqueness (2025)

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Low

FDAAug 8, 2025Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

IntelliSpace Cardiovascular (Philips) – outdated info (2025)

Software issue that results in the display of outdated information.

Low

FDAAug 8, 2025Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Class IIModerate

FDAAug 8, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

FloPatch FP120 (Flosonics) – expiry date error (2025)

Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

Low

FDAAug 7, 2025Nationwide• Flosonics Medical (R/A 1929803 ONTARIO CORP.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada

CADD Medication Cassette (ICU Medical) – bag weld weakness (2025)

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Moderate

FDAAug 6, 2025Nationwide• ICU Medical Inc.