FDA Device recall Z-1901-2025
Access Testosterone assay, Catalog Number 33560
- FDA Device
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of Access Testosterone assay, Catalog Number 33560 by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1901-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-05 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | FL |
Product
Access Testosterone assay, Catalog Number 33560
Reason
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.
Identifiers
| code_info | UDI-DI: 15099590231347; Serial Number: 538081 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Beckman Coulter
- IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997
FDA Device · Class II · 2026-10-21 · Beckman Coulter - DxU 840m Iris, REF: C76947
FDA Device · Class II · 2026-10-21 · Beckman Coulter - DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
FDA Device · Class II · 2026-10-14 · Beckman Coulter - DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3…
FDA Device · Class II · 2026-10-14 · Beckman Coulter - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C…
FDA Device · Class II · 2026-08-26 · Beckman Coulter
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1901-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.