The Access TSH — Class II medical device recall Z-0094-2025
Ongoing recall by Beckman Coulter, Inc., reported 2024-10-23, distributed nationwide. Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results
| Recall number | Z-0094-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-08-28 |
| Classified | 2024-10-16 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, ES, FR, GB, HR, IE, IT, SK |
| Quantity | 2,805 units |
| UPC / GTIN / UDI-DI | 15099590744373 |
| Lot numbers | 234251, 338057, 338367, 338724, 339117, 439341 |
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 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.
Reason for recall
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0094-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.