Beckman Coulter, Inc. recalls
14 recalls.
- ROTOR ASSY-SW41 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 28, 2026 · Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break... - ROTOR ASSY-SW40 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 28, 2026 · Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a... - IQ200 SPRINT recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 21, 2026 · The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however... - DxU 840m Iris recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported October 21, 2026 · The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however... - DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE recall (Beckman Coulter Inc.)
Medical deviceClass IIReported October 14, 2026 · Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical... - DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE recall (Beckman Coulter Inc.)
Medical deviceClass IIReported October 14, 2026 · Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical... - Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or... recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 26, 2026 · a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by... - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or... recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 26, 2026 · a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by... - REF # D23354 recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 12, 2026 · Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." - REF # D23352 recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 12, 2026 · Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." - Access Total T4 Calibrator recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported April 29, 2026 · Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product... - CellMek SPS Sample Preparation System recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported February 11, 2026 · Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching... - Beckman Coulter UniCel Dxl 800 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported January 14, 2026 · Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard... - Beckman Coulter UniCel Dxl 600 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported January 14, 2026 · Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard...