Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23530 |
| Brand Name: | cobas e411 immunoassay analysers |
| Model: | All cobas e411 immunoassay analysers (both rack and disk versions), all software versions. |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | A new pinch valve (3 ASSY) for the cobas e 411 analyzer (disk and rack system) was released in April 2018. With the release of pinch valve 3 ASSY it was expected that the pinch valve tubing replacement would be performed by the Field Service Representative (engineer) during the yearly maintenance service. If the instrument performs more than 50,000 tests per year, the pinch valve tubing must be replaced every six months by the Field Service Representative (engineer). |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/8/2018 |
