Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36585 |
| Brand Name: | BOND Ready-To-Use Primary Antibody Synaptophysin (27G12) |
| Model: | |
| Affected: | Lots - 83059, 83607, 83992, 84289, 84733, 85058, 85998, 86360, 86779, 87306,87568, 87814, 87997 |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | Leica Biosystems Newcastle Ltd |
| Issue: | 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. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/2/2026 |
