Murex Hbsag Version 3 Hepatitis B Surface Antigen Immunoassay
Recall Summary DiaSorin Biotech is recalling Murex HBsAg Version 3, a test used to detect hepatitis B surface antigen in blood samples. The product is being returned to the supplier, though the specific reason for the recall is not detailed in this notice. The recall affects hospitals, pharmacies, and laboratories in New Zealand.
- Recalling firm
- DiaSorin Australia Pty Ltd
- Product
- Murex HBsAg Version 3 Hepatitis B Surface Antigen Immunoassay. [Device]. Affected: Batch numbers - A009510, A011310, A015810, A017811,A023010,A02310, A012410, A014310, A017710, A020211, A022910
- Reason
- 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),...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-04-09
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/008c1d0b-41e7-46af-9c69-61eac91478ce