Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37077 |
| Brand Name: | EBVP3 EntericBio Viral Panel 3, molecular, 120 tests |
| Model: | Affected lot number - 25878 |
| Affected: | Additional (lot # 26610 and 26644) |
| Software version: | |
| Recalling Organisation: | Ngaio Diagnostics Ltd 81 Halifax Street East NELSON |
| Contact Information: | |
| Manufacturer: | Serosep Limited |
| Issue: | A manufacturing operator error was identified during packaging of the EntericBio® Viral Panel pouches, the operator did not follow the approved Standard Operating Procedure (SOP), resulting in pouches not being fully heat sealed. This led to incomplete package seals. The issue was identified as an operator error due to non-compliance with the established manufacturing procedure. The risk is that the pouches are not fully heal sealed causing invalid results and increase number of IAC failures. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/7/2026 |
