Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20970 |
| Brand Name: | UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System |
| Model: | |
| Affected: | All Software Versions |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Beckman Coulter Inc |
| Issue: | The manufacturer has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/12/2016 |
