Class IIOngoingZ-0752-2026
GET TESTED INTERNATIONAL AB recalls Thyroid TSH Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Radioimmunoassay, Thyroid-Stimulating Hormone recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–4 of 4 recalls
Class IIOngoingZ-0216-2026
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer
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…
Beckman Coulter, Inc.MNOct 29, 2025
Class IIOngoingZ-1926-2025
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly.…
Beckman Coulter, Inc.MNJun 18, 2025
Class IIOngoingZ-1913-2025
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Beckman Coulter, Inc.MNJun 11, 2025