Access TSH assay reagent packs may produce erroneously low results
Certain lots of Beckman Coulter Access TSH reagent packs may produce erroneously low thyroid-stimulating hormone results. Affected kits should be verified before clinical use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for a diagnostic assay that may produce erroneous test results, which could lead to misdiagnosis or delayed diagnosis. No hospitalizations, injuries, or deaths have been reported, placing it within the High severity category for risk-of-harm products without reported injury.
Plain-English summary
Beckman Coulter, Inc. is recalling certain lots of Access TSH (3rd IS) reagent packs used with the Access Immunoassay Systems. The Access TSH assay is an in vitro diagnostic test that measures thyroid-stimulating hormone levels in blood samples. TSH measurements are used in the diagnosis of thyroid and pituitary disorders.
Certain lots of the Access TSH reagent packs may produce erroneously low TSH results. Erroneous results could lead to misdiagnosis or delayed diagnosis of thyroid or pituitary conditions.
Approximately 2,805 units have been distributed worldwide, including throughout the United States and in Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, and the United Kingdom. The affected lot numbers are 339117, 338724, 439341, 338367, 338057, and 234251.
Healthcare providers and laboratories using affected lot numbers should contact Beckman Coulter for guidance on replacement products or appropriate follow-up procedures. Patients who may have been tested using these reagent packs should consult their healthcare provider to discuss the potential impact on previous test results.
The recalled product
- Product
- 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…
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 2,805
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI/DI 15099590744373
- Lot Numbers: 339117
- 338724
- 439341
- 338367
- 338057
- 234251
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Beckman Coulter, Inc.
See all →- SevereBeckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- SevereBeckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
Same hazard · diagnostic error
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
Similar recalls
- HighBeckman Coulter PTH Assay Reagent Packs Recalled for Filling Defects
FDA (Devices) · 2025-01-15
- HighMedical Device Recall: PTH Assay on DxI 9000 Analyzer May Produce Inaccurate Results
FDA (Devices) · 2024-12-18
- LowBeckman Coulter Access Total T3 Reagent Recalled for Negative Bias
FDA (Devices) · 2012-08-29
- ModerateBeckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs
FDA (Devices) · 2015-09-09
- HighBeckman Coulter Recalls Access Free T3 Assay Kits Due to Result Shifts
FDA (Devices) · 2016-07-06
- HighBeckman Coulter Free T3 Reagent Test Kit Recalled for Falsely Elevated Results
FDA (Devices) · 2023-04-26