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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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
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.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
Similar recalls
- HighBeckman Coulter Recalls UniCel DxH 800 Cellular Analysis System
FDA (Devices) · 2017-01-18
- HighBeckman Coulter Recalls UniCel DxH 600 and DxH 800 Analysis Systems
FDA (Devices) · 2014-07-02
- HighBeckman Coulter Recalls UniCel DxH 800 and DxH 600 Analysis Systems
FDA (Devices) · 2014-07-02
- HighBeckman Coulter Recalls UniCel DxH 800 and DxH 600 Systems
FDA (Devices) · 2016-09-14
- HighBeckman Coulter DxH 600 Cellular Analysis System Recall for Blast Detection
FDA (Devices) · 2017-01-18
- ModerateBeckman Coulter Recalls UniCel DxH Analysis Systems for Optical Defect
FDA (Devices) · 2014-07-02