Beckman Coulter, Inc.: Medical Device Recalls in 2025

According to to data from the FDA, there were 28 medical device recalls made by Beckman Coulter, Inc. in 2025. See the details of the recalls below.

You can see similar recalls for other firms.

• Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
• CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
• DxI 9000 Access Immunoassay Analyzer, Part Number C11137
• Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
• Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
• DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
• DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
• DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
• UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
• Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
• DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
• DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
• UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
• Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
• DxI 9000 Access Immunoassay Analyzer C11137
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer
• Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells.
• DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
• Access Testosterone assay, Catalog Number 33560
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
• Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
• Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
• Access 2 Immunoassay Analyzer, Catalog Number 81600N
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278