Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21823 |
| Brand Name: | Abbott RealTime HIV-1 Qualitative |
| Model: | |
| Affected: | List 04N66-90 |
| Software version: | |
| Recalling Organisation: | Abbott Australasia Pty Ltd (NZ) Abbott Laboratories NZ 4 Pacific Rise, Mt Wellington Auckland 1060 |
| Contact Information: | 61 2 93849717 |
| Manufacturer: | Abbott Laboratories |
| Issue: | For plasma samples, RealTime HIV-1 Qualitative may exhibit false Not Detected results for HIV samples between 110 Copies/mL (Limit of Detection) and 336 Copies/mL. For Dried Blood Spot (DBS) samples, Abbott RealTime HIV-1 Qualitative performs in accordance with the detection rate within the RealTime HIV-1 Qualitative package insert for DBS sample types. No action is required for DBS samples. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/8/2017 |
