Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29720 |
| Brand Name: | cobas pure e 402 analytical unit and cobas e 801 analytical unit |
| Model: | cobas 8000 core unit, cobas e 801 analytical unit, cobas pure e 402 analytical unit, cobas pure sample supply unit, cobas pro sample supply unit, cobas pro SSU. |
| Affected: | |
| Software version: | cobas pure system SW v. 01-01 and 01-02, cobas pro INSTALL SW v. 01-01 to 02-02, c8000 v. 06-01 to 06-08 |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | The manufacturer is advising that a software issue may occur on the cobas pure e 402 an cobas pro/cobas 8000 e 801 analytical units. With Quick Start Mode active, the issue may occur when Rinse Pre-wash Sipper Flow Path or Wash Sippers Flow Path option Pre-Wash is performed, and the system starts afterwards. It may also occur when Finalization, System Wash or Wash Sippers Flow Paths option All is performed, and the Prime System Reagents Flow Path option Reagent Probe is executed later and the system starts afterwards. The chain of events causing the failure is very complex, diverse and several steps must be cumulatively present. This may lead to a Pre-Wash assay being washed with PreClean II M diluted with system water at run start and to potentially affect results of some Pre-Wash assays, either increased or decreased recovery/false high or low results depending upon the affected assay. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/9/2022 |
