Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21324 |
| Brand Name: | Beckman Coulter UniCel system |
| Model: | |
| Affected: | UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i systems. |
| 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: | In April 2017 the manufacturer issued an Urgent Medical Device Recall. As a follow up to this notification, the Access BR Monitor Instructions for Use (IFU) will be updated. The updated IFU will reflect the 95th percentile upper reference limit (URL) value for a healthy population, which was determined to be 23.5 U/mL. There is no change to the Access BR Monitor assay. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/10/2017 |
