Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37627 |
| Brand Name: | cobas® c 303 |
| Model: | |
| Affected: | Multiple serial numbers |
| 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 where vacuum tubing of the cell rinse unit of the cobas® c 303 analytical unitprematurely deteriorated. Investigations confirmed the issue. In the event of small pinholes or cracks, no clearimpact on analytical performance was identified. However, in case of tubing rupture, the following can occur as aresult of the issue: 1. Undetected leakage: Fluid may drip into random reaction cells. 2. Result impact: Increased risk of erroneous patient and QC results. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/9/2026 |
