Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14153 |
| Brand Name: | Beckman Coulter UniCel DxI and DxC Access Immunoassay Systems |
| Model: | Models: DxI 800, DxI 600, DxC 660i, 680i, 860i, 880i |
| Affected: | Specified serial number ranges |
| 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: | Improper tubing installation by the customer during routine maintenance may prevent the DxI and DxC systems from washing reaction vessels properly and may lead to erroneous test results. Note - This matter was initiated in 2011 but was not advised as a recall action at the time. Information received in retrospect following an audit of the manufacturer's CAPA files. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 31/1/2013 |
