FDA Device recall Z-0428-2026
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260
- FDA Device
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260 by Beckman Coulter, citing an internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to ent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0428-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-01 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
Product
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Reason
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
Identifiers
| code_info | A71460, UDI/DI 15099590369224, Serial Numbers: 902515, 902529, 902528, 902534, 902526, 902527, 902523, 902522, 902524,…A71460, UDI/DI 15099590369224, Serial Numbers: 902515, 902529, 902528, 902534, 902526, 902527, 902523, 902522, 902524, 902505, 902578, 902579, 902545, 902530, 902531, 902581, 902504, 902514, 902525, 902535, 902566, 902516, 902518, 902532, 902555, 902558, 902564, 902519, 902521, 902559, 902511, 902549, 902554, 902547, 902582, 902583; A30260, UDI/DI 15099590341602, Serial Numbers: 902536, 902541, 902517, 902563, 902565, 902557, 902513, 902507, 902543, 902560, 902562, 902506, 902508, 902574, 902533, 902572, 902540, 902569, 902568, 902577, 902510, 902580, 902567, 902573, 902570, 902571, 902538, 902553, 902552, 902512, 902539, 902561, 902575, 902544, 902542, 902556, 902537, 902509, 902520, 902546, 902548, 902551, 902550, 902576. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0428-2026%22
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