Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24518 |
| Brand Name: | Access Family of Immunoassay Systems |
| Model: | |
| Affected: | Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel,DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and 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: | The manufacturer has identified a potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays following a field action from 2017 (FA-30796), which tested biotin levels up to 100 ng/mL. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/4/2019 |
