Reported Jun 18, 2025 · Ongoing

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

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
    • running software versions 1.20
Lot codes and dates
  • UDI-DI15099590732103
  • Serial Numbers

    224 of 224 codes

    • 300144
    • 300145
    • 300148
    • 300150
    • 300153
    • 300154
    • 300155
    • 300156
    • 300157
    • 300158
    • 300161
    • 300166
    • 300168
    • 300171
    • 300174
    • 300175
    • 300178
    • 300182
    • 300183
    • 300186
    • 300190
    • 300191
    • 300192
    • 300193
    • 300194
    • 300198
    • 300200
    • 300201
    • 300204
    • 300205
    • 300206
    • 300208
    • 300209
    • 300210
    • 300211
    • 300212
    • 300213
    • 300214
    • 300215
    • 300217
    • 300218
    • 300219
    • 300221
    • 300225
    • 300226
    • 300228
    • 300231
    • 300232
    • 300234
    • 300235
    • 300236
    • 300240
    • 300242
    • 300249
    • 300250
    • 300252
    • 300255
    • 300266
    • 300267
    • 300270
Amount recalled
324 units

Where it was sold

  • Nationwide

Why it was recalled

A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

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.