Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20574 |
| Brand Name: | BK Virus R-gene |
| Model: | 69-013B |
| Affected: | Lot numbers: 1003909940 1004754140 and 1004764070 |
| 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 compaint about difficulties to interpret low viral load in whole blood samples, an investigation showed that the sensitivity of the BK Virus R-gene® claimed in the IFU for whole blood was not confirmed. The issue is only impacting whole blood samples with a low viral load, where amplification leads to creeping/flat curves difficult to interpret. This issue has no impact on negative results or on high positive samples, as the amplification curves are well identified. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/8/2016 |
