| TGA Action ID |
RC-2026-RN-00738-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
cobas c 303 analytical unit. An in vitro diagnostic medical device (IVD)
Material Number: 09031529001 |
| ARTG Number |
197926 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A premature deterioration in the vacuum tubing of the cell rinse unit in the cobas c 303 analytical unit has been identified.
A small defect like pinholes or cracks will not have an impact on analytical performance of the unit. However, a systemic failure will only occur when there is tubing rupture, resulting in dripping in random cells and causing erroneous results impacting patient results.
To date, there have been no reported adverse events or patient harm related to this problem. |
| Instructions for Customers/Users |
Customers can continue to use the system.
Daily QC measurement with QC panel of available tests on the analyser before releasing patient results. In case you identify a systematic deviation of multiple results of the QC, immediately stop usage of the cobas® c 303 because a tubing rupture cannot be excluded. Please contact a Roche Service Representative for troubleshooting and potential tubing replacement.
No general recommendations with respect to the review of previous results can be given by using the cobas c 303 analytical unit. Customers should follow their standard laboratory operating procedures.
To prevent occurrences of premature rupture, Roche Service and Support team will replace the tubing on all affected instruments within the next 12 months. |
| Action Commencement Date |
24/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 645 619 - Maria Ziada, Roche Service and Support team |