Reported Feb 12, 2025 · Completed

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

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?

  • Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Lot codes and dates
  • UDI/DI 15099590732103
  • serial numbers

    61 of 61 codes

    • 300208
    • 300201
    • 300184
    • 300185
    • 300169
    • 300225
    • 300175
    • 300172
    • 300221
    • 300209
    • 300211
    • 300212
    • 300213
    • 300214
    • 300215
    • 300210
    • 300174
    • 300226
    • 300204
    • 300216
    • 300217
    • 300170
    • 300220
    • 300176
    • 300188
    • 300199
    • 300200
    • 300177
    • 300222
    • 300224
    • 300173
    • 300181
    • 300202
    • 300191
    • 300223
    • 300171
    • 300186
    • 300190
    • 300203
    • 300178
    • 300195
    • 300189
    • 300198
    • 300227
    • 300228
    • 300168
    • 300194
    • 300205
    • 300206
    • 300207
    • 300197
    • 300218
    • 300179
    • 300182
    • 300192
    • 300219
    • 300193
    • 300183
    • 300180
    • 300187
Amount recalled
61 units

Where it was sold

  • Nationwide

Why it was recalled

A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Beckman Coulter, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:43 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.