The Recall Desk
ModerateFDA (Devices)·Z-0236-2018·Announced 2017-12-20

Beckman Coulter UniCel DxH800 Automated Hematology Analyzer Recall

Beckman Coulter is recalling 15 UniCel DxH800 automated hematology analyzers because the Single-Tube Station shield may interfere with sample aspiration.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical interference issue without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Beckman Coulter Inc. is recalling 15 units of the UniCel DxH800 automated hematology analyzer, part numbers 629029 and B24802. The recall involves specific serial numbers listed in the agency documentation.

The recall was initiated because the shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. This defect could potentially affect the accuracy of the automated hematology analysis.

The affected units were distributed to locations in California, Arkansas, Hawaii, Ohio, Washington, Maryland, Canada, and Japan. Users of these devices should contact Beckman Coulter Inc. for instructions on how to resolve the issue.

The recalled product

Product
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
15

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 (14)

  • Serial Numbers: B24802: AW10161
  • AW10154
  • AZ34449
  • AZ34447 629029: AT40563
  • AT06096
  • AT06095
  • AT02044
  • AW05080
  • AW05072
  • AW05066
  • AT50679
  • AS49422
  • AS36312
  • AS23151

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · mechanical interference

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