Lightmix® Ebv Fluorescence Loss
- Recalling firm
- Roche Diagnostics (NZ) Ltd
- Product
- LightMix® EBV fluorescence loss. [Device]. Affected: lot 34182503
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-09
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/314cd8eb-324c-4986-8693-82e2e0b992b4