Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21146 |
| Brand Name: | bioMerieux R-Gene BK Virus kit. |
| Model: | |
| Affected: | bioMerieux R-Gene BK Virus kit on SmartCycler 2.0 platform |
| Software version: | |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | Biomerieux SA |
| Issue: | Following a customer complaint and an internal investigation, it has been confirmed that when testing weak viral load samples in conjunction with BK Virus R-gene kit on SmartCycler 2.0 platform, negative results may be obtained. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/2/2017 |
