Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36530 |
| Brand Name: | LightMix® EBV fluorescence loss |
| Model: | |
| Affected: | lot 34182503 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | A performance issue of the Parameter-Specific Reagents (PSR) has been identified in LightMix Kit for the detection of Epstein-Barr Virus (EBV) (product number 05943612001), lot 34182503, resulting in loss of fluorescence. The affected lot will no longer be distributed or used and replacement kits will be provided. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/2/2026 |
