Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37768 |
| Brand Name: | Access HIV Ag/Ab Combo Calibrator |
| Model: | Ref #C39451 |
| Affected: | Multiple lots |
| 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 through internal investigation that the calibrator card 2D barcode for the Access HIV Ag/Ab combo calibrator contain reversed assay calibrator value assignments. As a result, the DxI 9000 Access Immunoassay Analyzer attributes the HIV-Ag calibrator assigned values to the HIV-Ab assay, and the HIV-Ab calibrator assigned values to the HIV-Ag assay. Access HIV Ag/Ab combo Calibrator may generate false Nonreactive or Reactive Access HIV Ag/Ab combo result interpretations. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/10/2026 |
