| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00398-1 |
| Product Name/Description |
Sample Probe Connector used with cobas modules. An in vitro diagnostic medical device (IVD)
Probe Sample
Material Number: 04547241001
Systems affected: cobas c 501/502/701/702 modules
Sample Probe
Material Number: 04945794001
Systems affected: cobas 8000 ISE module 1800
Multiple Serial Numbers
ARTG Number: 173887 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Roche has identified that in very rare cases, a disturbance of the sample liquid level detection (LLD) may occur due to a fretting corrosion on the sample probe connector. In such instances, the affected sample probe may not aspirate the sample material at the correct level; accordingly the probe may not be washed adequately, resulting in the possibility of sample carryover.
This issue, which was detected during an internal investigation, was caused by a production change in the sample probe connector type, potentially causing fretting corrosion on the sample probe connector. To date, Roche have not received any complaints about this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is requesting that customers check the sample probe in use in their analyser to determine if the sample probe is from the potentially affected serial/lot numbers. If so, customers are advised to contact Roche to discuss an exchange. Until the sample probe is exchanged, users are requested to follow the detailed instructions provided in the customer letter.
This action has been closed-out on 23/03/2018. |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |