Database updated: 6 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37865 |
| Brand Name: | RIDA Setup 3.01.05 |
| Model: | RIDA Xplore System (96521) and HighPlex System (91501) |
| Affected: | |
| Software version: | |
| Recalling Organisation: | AusDiagnostics NZ Ltd 156B Bush Road Albany Auckland 0632 |
| Contact Information: | |
| Manufacturer: | AusDiagnostics Pty Ltd |
| Issue: | A software defect was identified in RIDA® Setup v3.01.05, affecting the RIDA®Xplore System (96521) and HighPlex System (91501) The defect occurs only when all the following conditions are met: · Samples are entered manually; · The POSCON option is selected; and · The positive control is placed in any position other than the last position in the run. Under these conditions, the software repositions a sample without updating the corresponding sample identifier, resulting in a mismatch between the physical sample position and the assigned sample label. This creates the potential for incorrect sample identification and assignment of results to the wrong specimen. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/11/2026 |
