Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21340 |
| Brand Name: | SD BIOLINE HIV Ag/Ab Combo, SD03FK30 |
| Model: | |
| Affected: | Lot numbers, 03BDA005A, 03BDA006A, 03BDA006B, 03BDB001C |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd - Rapid Diagnostics Divison Ground Floor, Bldg. D 4 Pacific Rise Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 466 951 |
| Manufacturer: | Alere Medical Co Ltd |
| Issue: | The manufacturer received complaints and confirmed that certain lots did not meet the performance claim for analytical sensitivity of p24 antigen (the claimed detection limit in the package insert is 2 IU/mL, however the lots listed detect a concentration of 16 IU/mL.) |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/4/2017 |
