Access Testosterone assay — Class II medical device recall Z-1901-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-06-11, distributed in FL. Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cros
| Recall number | Z-1901-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-05-05 |
| Classified | 2025-06-02 |
| Reported by FDA | 2025-06-11 |
| Distributed | FL |
| Countries outside the US | AE, VN |
| Quantity | 70 units |
| UPC / GTIN / UDI-DI | 15099590231347 |
| Serial numbers | 538081 |
| Model numbers | 33560 |
Product
Access Testosterone assay, Catalog Number 33560
Reason for recall
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient 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-1901-2025. 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.