Recall database

Radioimmunoassay, Cortisol recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0215-2026

Beckman Coulter, Inc. recalls DxC 500i Clinical Analyzer Modules

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering add…

Cortisol Radioimmunoassay
Software design

Beckman Coulter, Inc.MNOct 29, 2025

Class IIOngoingZ-0032-2026

Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress wi…

Cortisol Radioimmunoassay
Software Design Change

Beckman Coulter Inc.CAOct 8, 2025