Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21676 |
| Brand Name: | Alere HIV Combo |
| Model: | |
| Affected: | 20 Tests Kits catalogue number 7D2846, Lot number 80671K100C |
| 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: | Internal investigations have identified that when testing with EDTA whole blood samples, may exhibit increased frequency of a red bar in the antigen (p24) result window, which could be interpreted as a false positive result. These bars may be faint. Antigen (p24) performance with other sample types continues to perform as per product specifications. Performance for HIV-1 and HIV-2 antibody is as per product specifications. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/7/2017 |
