FDA Device recall Z-1326-2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 by Beckman Coulter, citing the DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event fo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1326-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-13 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Reason
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
Identifiers
| code_info | UDI-DI: 15099590732103; Serial Numbers: 300116 300117 300123 300124 300126 300128 300129 300130 300131 300132 300133 30…UDI-DI: 15099590732103; Serial Numbers: 300116 300117 300123 300124 300126 300128 300129 300130 300131 300132 300133 300134 300135 300136 300137 300138 300139 300141 300142 300143 300144 300145 300147 300148 300149 300150 300151 300152 300153 300154 300155 300156 300157 300158 300161 300162 300163 300164 300166 300167 300168 300169 300170 300171 300172 300173 300174 300176 300177 300178 300179 300181 300182 300183 300186 300188 300189 300190 300191 300192 300193 300194 300195 300197 300198 300199 300200 300201 300202 300203 300204 300205 300206 300207 300208 300209 300210 300211 300212 300213 300214 300215 300216 300217 300218 300219 300220 300221 300222 300223 300224 300225 300226 300227 300228 300229 300230 300231 300232 300233 300234 300235 300236 300237 300238 300239 300240 300241 300242 300243 300244 300245 300246 300247 300248 300250 300251 300252 300253 300254 300255 300256 300257 300258 300259 300260 300261 300263 300264 300266 300267 300268 300269 300270 300271 300272 300273 3 |
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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-1326-2025%22
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