The Recall Desk
HighFDA (Devices)·Z-2574-2025·Announced 2025-09-24

DxH 800 hematology analyzers recalled over erroneously high hemoglobin results

UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states the analyzer can produce erroneously high patient results and no injuries are reported.

Plain-English summary

The UniCel DxH 800 COULTER Cellular Analysis System configured with the LED HGB Photometer, REFs B24802, 629029 and B63322, with UDIs 15099590672423, 15099590381646 and 15099590687922, is being recalled. Affected serial numbers include AT38527, AU02008, AU10078, AV28630 and AW13, with the full list in the recall notice. Distribution was nationwide in the United States and internationally.

Hematology analyzers configured with HGB photometers may produce erroneously high hemoglobin results on samples with elevated white blood cell counts. The FDA classified the action as Class II.

Laboratories operating these analyzers should follow the manufacturer's instructions, including any guidance on reviewing results already reported.

The recalled product

Product
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDIs: 15099590672423
  • 15099590381646
  • 15099590687922/ Serial Numbers: AT38527
  • AU02008
  • AU10078
  • AV28630
  • AW13187
  • AW29123
  • BC18100
  • RBB03201
  • AW43276
  • AY06074
  • AY06092
  • AY41556
  • AY43605
  • AZ02030
  • AZ03041
  • AZ18245
  • AZ22329
  • AZ39513

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · erroneous results

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