Bond Ready-to-use Primary Antibody Synaptophysin (27g12)
- Recalling firm
- Leica Microsystems Pty Ltd, New Zealand Branch
- Product
- BOND Ready-To-Use Primary Antibody Synaptophysin (27G12). [Device]. Affected: Lots - 83059, 83607, 83992, 84289, 84733, 85058, 85998, 86360, 86779, 87306,87568, 87814, 87997
- Reason
- The manufacturer has recently become aware that the IFU for the product mentioned above IFU incorrectly lists normal tonsil (positive) and normal prostate (negative) as control tissues. There is no impact on antibody performance and risk is limited to assay invalidation., This was due to an error made during the revision of the IFU. There is no impact on antibody performance and risk is limited to assay invalidation. However, an outcome, Leica Biosystems has decided to notify customers of this issue.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-25
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a51e1845-9ec1-4f27-80e8-0c29f639774e