Access Intact PTH assay — Class II medical device recall Z-0803-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-01-15, distributed nationwide. Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled
| Recall number | Z-0803-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-11-26 |
| Classified | 2025-01-03 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 362 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 15099590201937 |
| Lot numbers | 339071 |
| Model numbers | A16972 |
Product
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
Reason for recall
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.
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-0803-2025. 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.