Access TSH (3rd IS) recallZ-0094-2025 · Beckman Coulter, Inc. · initiated Aug 28, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
FDA root cause category: Under Investigation by firm
What the company is doing
Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via US mail and email. The notice explained the problem, potential impact, requested the discontinuation of use and destruction of the affected product. The notice should be shared with all impacted parties and a retrospective review of patient tests is recommended. For questions regarding this notice, please contact Customer Support Center: . From our website: http://www.beckmancoulter.com . For customers in the United States, if you need replacement product: o Call Client Services at 1-800-854-3633
Recall details
- Recall number
- Z-0094-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 28, 2024
- Posted by the FDA
- Oct 16, 2024
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 2805 units
- Product code
- JLW
- FDA submissions
- K221225
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
Product description
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.
Code information (models, lots, serial numbers)
UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Access TSH (3rd IS) C28643Beckman Coulter, Inc. · Radioimmunoassay, Thyroid-Stimulating Hormone1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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