Reported Nov 12, 2025 · Ongoing

Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

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 UniCel DxI 800
  • Part Numbers
    • 973100
    • A71456
    • Photometric Chemistry Analyzer
Lot codes and dates
    • 973100
    • UDI/DI 15099590265373 (Chaska)
  • Serial numbers

    302 of 302 codes

    • 610458
    • 610455
    • 610679
    • 610579
    • 610432
    • 610430
    • 610434
    • 610664
    • 610682
    • 610765
    • 610500
    • 610541
    • 610544
    • 610545
    • 610562
    • 610547
    • 610585
    • 610595
    • 610475
    • 610453
    • 610781
    • 610580
    • 610444
    • 610704
    • 610586
    • 610684
    • 610589
    • 610588
    • 610493
    • 610659
    • 610570
    • 610498
    • 610748
    • 610496
    • 610560
    • 610573
    • 610574
    • 610577
    • 610601
    • 610651
    • 610680
    • 610642
    • 610641
    • 610683
    • 610747
    • 610468
    • 610772
    • 610441
    • 610476
    • 610489
    • 610488
    • 610492
    • 610532
    • 610534
    • 610533
    • 610535
    • 610640
    • 610457
    • 610464
    • 610790
  • Serial Numbers

    251 of 251 codes

    • 630104
    • 630105
    • 630160
    • 630159
    • 630162
    • 630110
    • 630140
    • 630175
    • 630143
    • 630103
    • 630108
    • 630174
    • 630099
    • 630112
    • 630113
    • 630136
    • 630107
    • 630102
    • 630100
    • 630106
    • 630115
    • 630114
    • 630132
    • 630111
    • 630101
    • 630109
    • 630146
    • 630139
    • 630116
    • 630126
    • 630117
    • 630118
    • 630120
    • 630119
    • 630121
    • 630122
    • 630123
    • 630124
    • 630125
    • 630129
    • 630128
    • 630130
    • 630131
    • 630134
    • 630135
    • 630137
    • 630141
    • 630142
    • 630133
    • 630127
    • 630164
    • 630172
    • 630173
    • 630144
    • 630156
    • 630145
    • 630157
    • 630158
    • 630155
    • 630154
Amount recalled
657 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

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.

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

Want the full recall guide?

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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, 5:40 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.