The Recall Desk
HighFDA (Devices)·Z-2158-2017·Announced 2017-05-31

Beckman Coulter UniCel DxH 600 Recall for Erroneous WBC Differential Results

Beckman Coulter is recalling UniCel DxH 600 systems due to a software issue that 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. The hazard involves a risk of erroneous diagnostic results (incorrect white blood cell differentials) which could impact patient care, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Beckman Coulter Inc. is recalling the UniCel DxH 600 Coulter Cellular Analysis System (Catalog No. B23858) under FDA recall number Z-2158-2017. The recall involves 1,408 units total, with 998 units distributed in the United States and the remainder distributed worldwide across numerous countries. The recall covers all software versions of the device.

The recall is issued because there is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential. This event pattern may not trigger a system flag or message. Consequently, events associated with the unusual light scatter pattern may be incorrectly removed from analysis, which can result in an erroneous differential result.

Healthcare facilities and laboratories using the UniCel DxH 600 system should contact Beckman Coulter for instructions on how to address the software issue. The source text does not specify a specific action for consumers, as this is a medical device used in professional settings.

The recalled product

Product
UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
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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