Estrone RIA — Class II medical device recall Z-2152-2025
Ongoing recall by Beckman Coulter Inc., reported 2025-07-30, distributed in NC. A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in
| Recall number | Z-2152-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-06-12 |
| Classified | 2025-07-21 |
| Reported by FDA | 2025-07-30 |
| Distributed | NC |
| Countries outside the US | AR, AT, BE, CA, DE, FR, GR, HU, IT, NL |
| Quantity | 496 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15099590211615 |
| Lot numbers | 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C |
| Model numbers | DSL8700 |
Product
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Reason for recall
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
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-2152-2025. 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.