Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22805 |
| Brand Name: | cobas e 801 syringe plunger issue |
| Model: | cobas e801 |
| 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: | The manufacturer has received complaints describing an issue with the syringe plunger on the cobas e 801 module PreWash syringe assembly. Investigations determined that the issue may also occur on the cobas e 801 module R1 or R2 reagent assembly. Depending on the affected syringe, R1, R2 or PreWash, liquids may not be pipetted correctly due to the syringe plunger being damaged. Depending on how the seal pieces are assembled, it is possible that the plunger is mounted in a tilted position, which applies mechanical stress to the plunger. During the cobas e 801 module initialization steps when the largest stokes happen, the plunger may crack leading to an impaired syringe function. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/4/2018 |
