Beckman Coulter, Inc.: Medical Device Recalls in 2024

According to to data from the FDA, there were 21 medical device recalls made by Beckman Coulter, Inc. in 2024. See the details of the recalls below.

You can see similar recalls for other firms.

• Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
• The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
• Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
• The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
• Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
• DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
• DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
• Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
• DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
• Discrete photometric chemistry analyzer for clinical use.
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
• Access Total T4, REF 33800, IVD, thyroxine reagent assay.
• DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
• Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
• iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
• iQ Waste Well Adapter, Part Number: 700-3393
• REV 2 Flowcell Capsule Spare, Part Number: C04154
• Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
• Access Substrate, REF 81906, For use with the Access Immunoassay Systems