Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24311 |
| Brand Name: | cobas e 801 |
| Model: | |
| Affected: | cobas e 801 module, cobas e 801 analytical unit, ProCell II M |
| 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: | On affected cobas e 801 modules/analytical units, the ProCell II M flowpath is covered by a biofilm with ProCell II M resistant bacteria. If ProCell II M inside the flowpath is not exchanged regularly, bacteria can degrade the components of ProCell II M resulting in a reduced ECL signal generating capacity. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/3/2019 |
