Radioimmunoassay, Thyroid-Stimulating Hormone

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-12-01Open, ClassifiedNo Marketing Application

  Thyroid TSH Test

  Distribution without premarket approval/clearance.

• 2025-10-21Open, ClassifiedSoftware design

  DxI 9000 Access Immunoassay Analyzer, Part Number C11137

  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 additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

• 2025-06-06Open, ClassifiedNonconforming Material/Component

  DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

  A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation 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.

• 2025-06-05Open, ClassifiedSoftware design

  DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

  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.

• 2024-10-16Open, ClassifiedUnder Investigation by firm

  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.

  Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

• 2024-10-08Open, ClassifiedNonconforming Material/Component

  FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

  Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.

• 2018-05-04TerminatedError in labeling

  Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge

  The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

• 2018-05-04TerminatedError in labeling

  Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

  The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

• 2018-04-10TerminatedNonconforming Material/Component

  VITROS Immunodiagnostic Products TSH Reagent Pack

  VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.

• 2017-05-05TerminatedUnder Investigation by firm

  Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

  The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.