Reported Mar 19, 2025 · Ongoing

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

Beckman Coulter, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037

Is this the product you have?

    • DxI 9000 Access Immunoassay Analyzer
    • Catalog Number C11137
Lot codes and dates
  • UDI-DI15099590732103
  • Serial Numbers

    245 of 245 codes

    • 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
Amount recalled
245 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.