Health product recall

Unicel DxH Series Instruments

Last updated

Summary

Product
Unicel DxH Series Instruments
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Unicel DxH 900 Coulter Cellular Analysis System

More than 10 numbers, contact manufacturer.

C11478

Unicel DxH 600 Coulter Cellular Analysis System

BB49881

B23858

Unicel DxH 800 Coulter Cellular Analysis System

AU10078

629029

Unicel DxH 800 Coulter Cellular Analysis System

AW43276

629029

Unicel DxH 800 Coulter Cellular Analysis System

AZ46681

629029

Unicel DxH 800 Coulter Cellular Analysis System

AU10078

B24802

Unicel DxH 800 Coulter Cellular Analysis System

AW43276

B24802

Unicel DxH 800 Coulter Cellular Analysis System

AZ46681

B24802

Unicel DxH 690T Coulter Cellular Analysis System

BJ12047

C34520

Unicel DxH 690T Coulter Cellular Analysis System

BJ07013

C34520

Unicel DxH 690T Coulter Cellular Analysis System

BJ12046

C34520

Unicel DxH 690T Coulter Cellular Analysis System

BH24076

C34520

Issue

Beckman Coulter has identified a potential for erroneously high hemoglobin (Hgb) results on samples with elevated white blood cell (WBC) counts. This occurs on Unicel DxH series instruments configured with the led Hgb photometer. Falsely elevated Hgb results may observed in specimens with WBC counts > 30 x 10³ cells/μl.

Recall start date: August 6, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Health products - Medical devices - Haematology
Companies
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77942

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe