The Recall Desk
ModerateFDA (Devices)·Z-0237-2018·Announced 2017-12-20

Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue

Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a 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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a potential functional defect.

Plain-English summary

Beckman Coulter Inc. is recalling the UniCel DxH600 automated hematology analyzer, Part Number B23858. The recall involves 1 unit with Serial Number AZ06682. The product is a benchtop unit that is identical to the DxH 800 except for the absence of an instrument cart, computer stand, and connectivity capabilities.

The recall is being issued because the shield for the Single-Tube Station on the instrument may interfere with sample aspiration in the open vial position. This defect could potentially affect the accuracy of the hematology analysis performed by the device.

The affected unit was distributed to locations in California, Arkansas, Hawaii, Ohio, Washington, Maryland, Canada, and Japan. Users of this specific device should contact Beckman Coulter Inc. for instructions on how to resolve the issue.

The recalled product

Product
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
1

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 (1)

  • Serial Number AZ06682

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 · functional defect

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