Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21812 |
| Brand Name: | Abbott RealTime HIV-1 Assay |
| Model: | |
| Affected: | lots 474215 and lot 476139. |
| 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 Molecular Inc |
| Issue: | The manufacturer has become aware that all lots may exhibit a higher than expected rate of error codes. For plasma samples, all lots have the potential to exhibit false “Not Detected” results for HIV samples less than 120 Copies/mL when using 0.6 mL assay application. For Dried Blood Spot (DBS) samples when using a 1-Spot protocol associated with the RealTime HIV-1 Package Insert 51-608282, all lots are performing in accordance with the detection rate within the RealTime HIV-1 package insert for DBS sample types. It has been identified that Lot 476139 may exhibit a higher than expected rate of error codes, misquantitation, and the potential to not detect HIV samples. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/8/2017 |
