Reported Sep 24, 2025 · Ongoing

UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

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. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • UniCel DxH 690T COULTER Cellular Analysis System, configured
  • with the Led HGB Photometer REFC34520
Lot codes and dates
  • UDI15099590729110/
  • Serial Numbers
    • BD17734
    • BE12048
    • BE28105
    • BF14045
    • BF23096
    • BF46236
    • BG26135
    • BG50247
    • BH12019
    • BH43168
Amount recalled
N/A

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

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, 4:09 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.