Reported Mar 26, 2025 · Ongoing

Access 2 Immunoassay Analyzer, Catalog Number 81600N

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?

    • Access 2 Immunoassay Analyzer
    • Catalog Number 81600N
Lot codes and dates
  • UDI-DI15099590265380
  • Serial Numbers

    873 of 873 codes

    • 574626
    • 574627
    • 574839
    • 574840
    • 574841
    • 574842
    • 574852
    • 574853
    • 574854
    • 574378
    • 573724
    • 574432
    • 574538
    • 574907
    • 574497
    • 574303
    • 574184
    • 574218
    • 574219
    • 574305
    • 574332
    • 574333
    • 574345
    • 574346
    • 574414
    • 574451
    • 574581
    • 574582
    • 574583
    • 574584
    • 574726
    • 574727
    • 574728
    • 574729
    • 574730
    • 574731
    • 574732
    • 574733
    • 574920
    • 574922
    • 574923
    • 574955
    • 574957
    • 574958
    • 574959
    • 574984
    • 574985
    • 574986
    • 574987
    • 574811
    • 574160
    • 574161
    • 574167
    • 574168
    • 574169
    • 574171
    • 574177
    • 574178
    • 574179
    • 574180
Amount recalled
873 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test 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, 4:55 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.