Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36720 |
| Brand Name: | Murex HBsAg Version 3 Hepatitis B Surface Antigen Immunoassay |
| Model: | |
| Affected: | Batch numbers - A009510, A011310, A015810, A017811,A023010,A02310, A012410, A014310, A017710, A020211, A022910 |
| Software version: | |
| Recalling Organisation: | DiaSorin Australia Pty Ltd Suite 3 Level 3 68 Waterloo Road North Ryde NSW 2113 Australia |
| Contact Information: | |
| Manufacturer: | Diasorin Biotech |
| Issue: | The manufacturer has identified that specific lots of the Murex HBsAg Version 3 Immunoassay may generate invalid results and demonstrate reduced sensitivity. Internal testing showed that positive control results may fall below the acceptance criteria specified in the Instructions for Use (IFU); where this occurs, the assay is considered invalid and results must not be interpreted. Further investigation confirmed that the affected kits do not meet the analytical sensitivity claim stated in the IFU when evaluated against the WHO Third International Standard for HBsAg (NIBSC code: 12/226), although they continue to meet the minimum sensitivity requirements of the Common Specifications. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/4/2026 |
