Rida Setup 3.01.05
- Recalling firm
- AusDiagnostics NZ Ltd
- Product
- RIDA Setup 3.01.05. [Device]. Model: RIDA Xplore System (96521) and HighPlex System (91501)
- Reason
- 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...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-11-04
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/50b6effa-50a4-4963-8ddc-79c69f255630