Unicel DxH Series Instruments
Brand(s)
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 notifications for new and updated recalls and alerts by category.