Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19310 |
| Brand Name: | Roche Benchmark Ultra clinical chemistry analysers |
| Model: | 05342716001 |
| Affected: | Software Versions VSS 11.9 or higher |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Brand Name: | Roche Discovery Ultra clinical chemistry analyser |
| Model: | 05987750001 |
| Affected: | Software versions VSS 11.9 or higher |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | Internal investigations by Roche Diagnostics have uncovered the potential for incorrect slide staining (IHC/ISH) to occur on the BenchMark ULTRA instrument or DISCOVERY ULTRA instrument running Ventana System Software (VSS) 11.9 or higher, due to the possibility of a duplicate keycode error. The embedded software for the barcode reader has an identified issue, which on presentation of this error may result in two slides erroneously receiving the same stain protocol regardless of what should have been indicated in the software for that keycode. The barcode reader fails to purge previously read barcode information and applies the same protocol details to a subsequent slide. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/10/2015 |
