FDA Device recall Z-1235-2026
CellMek SPS Sample Preparation System, REF: C44603, with software
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of CellMek SPS Sample Preparation System, REF: C44603, with software by Beckman Coulter, citing sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which cou….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1235-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-23 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
CellMek SPS Sample Preparation System, REF: C44603, with software
Reason
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
Identifiers
| code_info | UDI-DI: 15099590750312. Software Version 2.3.90.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 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-1235-2026%22
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