The Recall Desk
HighFDA (Devices)·Z-2157-2017·Announced 2017-05-31

Beckman Coulter UniCel DxH 800 Recalled for Potential Data Errors

Beckman Coulter is recalling UniCel DxH 800 systems because a software issue may cause erroneous white blood cell differential results.

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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (erroneous medical test results) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Beckman Coulter Inc. is recalling the UniCel DxH 800 Coulter Cellular Analysis System (Catalog No. 629029, B24465, B24802, B66445, B68304, B63322) under FDA recall number Z-2157-2017. The recall involves 4,880 units total, with 2,119 units distributed in the United States and the remainder distributed worldwide.

The recall is due to a possibility of data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential. This pattern may not trigger a system flag or message, and associated events may be incorrectly removed from analysis, resulting in an erroneous differential result.

Healthcare facilities and users of the affected systems should contact Beckman Coulter for further instructions on how to address the potential software issue.

The recalled product

Product
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
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 (1)

  • all software versions

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · erroneous results

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