Recall MonitorHealth Products
Unicel DxH Series Instruments
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry, Health products - Medical devices - Haematology
Product: Unicel DxH Series Instruments
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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