| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00189-1 |
| Product Name/Description |
cobas p 512 pre-analytical system. An in vitro diagnostic device (IVD)
Material Number. 05083435001
Serial Number. 4741745 or lower
ARTG Number: 212706 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports overseas that sample tubes may not be correctly placed back in the Rack Tube Transport (RTT) after the de-capping process. This may result in open tubes being dropped within the cobas p 512 pre-analytical system, contaminating the system and potentially other samples. A false triggering or detection of the “READY” signal from the lifting gripper in the decapper causes the system to register that the motor motion is finished. The system then continues with the next process step and opens the gripper prematurely.
This issue may lead to contamination of the instrument and other samples. The risk to operator of contamination is less than remote. However, the contamination of other samples may lead to erroneous sample results with possible inappropriate diagnosis/treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche Diagnostics has developed a software patch (71829_p512) to correct the reported issue. The implementation of this software patch is mandatory and will be installed by a Roche Diagnostics Australia field service representative. Users are advised to monitor the system for the Error 140 “Missing Tube” until the software patch is installed. If this error code occurs, please clean all components in contact with the spillage (refer to Operator’s Manual v1.5). This action has been closed-out on 15/02/2017. |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |