Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-0673-2025
Ongoing recall by Beckman Coulter Inc., reported 2024-12-18. The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Acce
| Recall number | Z-0673-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2024-11-08 |
| Classified | 2024-12-11 |
| Reported by FDA | 2024-12-18 |
| Countries outside the US | AT, AU, BE, BH, BR, CH, CZ, DE, EG, ES, FR, GB, GH, HR, HU, IE, IL, IN, IT, KR, KW, MY, NL, NZ, PL, PT, SK, TW, ZA |
| UPC / GTIN / UDI-DI | 15099590201937 |
| Lot numbers | 338921, 339071, 372223, 439138, 439205, 439206, 439207, 439650, 439801, 439889, 440026, 440090, 472012, 472092, 472136, 472154 |
| Model numbers | A16972 |
Product
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
Reason for recall
The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.
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-0673-2025. 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.