Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22394 |
| Brand Name: | Roche OptiView DAB IHC Detection Kit |
| Model: | 06396500001 |
| Affected: | LOts: Y11625, Y15571, Y19271,and Y24225 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Brand Name: | Roche ultraView DAB IHC Detection Kit |
| Model: | 05269806001 |
| Affected: | Lots: Y09284, Y11687, Y11716, Y15384, Y17984, Y22153, Y18099, Y18069, Y19302 and Y22147 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Brand Name: | OptiView Amplification Kit |
| Model: | 06396518001 |
| Affected: | Lots: Y15435, Y19322 and Y22447 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Brand Name: | OptiView Amplification Kit (250 Test) |
| Model: | 06718663001 |
| Affected: | Lot: Y19318 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Brand Name: | Hematoxylin II |
| Model: | 05277965001 |
| Affected: | Lots: Y10759, Y13938, Y17402, Y17403, Y21312 and Y22561 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | Manufacturer has received increased customer complaints reporting leaking and sticking reagent dispensers. These reports are currently focused on horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.The manufacturer has identified the cause of the issue, and is working to correct it and additionally, has mandated specific requirements for slide controls for customers with affected product in inventory. An expanded scope notification: Two additional contributing factors were also identified: 1. Products intended for greater than 50 actuations 2. Products with emulsifiers These two contributing factors, when combined, exacerbate the issue and its occurrence in the market. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/8/2018 |
