| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00423-1 |
| Product Name/Description |
TCAutomation / enGen Laboratory Automation Systems. An in vitro diagnostic medical device (IVD)
Product Code: ENGEN
Recapper Caps
Product Code: 952238 or 6844286 only
Recapper Module (230V) or Recapper Module (110V)
Product Code: 952036-EG or 952136-EG
Rack Entry and Exit Module and/or Rack Exit Module
Product Code: 952020-EG/6844086 or 952019-EG/6844103
Storage Rack Slim 100 positions or Storage Rack 180 positions:
Product Code: 952075 or 952073 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Recapped tubes can lean in their storage holes, causing them to touch neighbouring tubes and interfere with the movement of the robot gripper. The gripper does not have enough space to properly place the tubes in the storage racks due to leaning tubes in the racks. There is a potential for the caps to fall off of or be knocked from sample tubes placed in the storage racks of entry/exit modules. There is also the possibility for the gripper to grab a tube at the wrong height and drop the tube in the entry/exit modules. These situations may result in splashing of bio-hazardous fluid, and sample cross-contamination may occur if there is an uncapped tube in the rack. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The rack profile configuration has been modified in a way that tubes are loaded to only every second position. Because existing rack is used, this does not require new software release for TCA. This modified rack profile configuration will prevent tubes to lean too close to the next one while loading it and thus preventing possible collision.
Thermo Fisher is recommending their customers to install the modified rack profile configuration. Installation of the modified rack profile can be done by authorised service engineer.
Thermo Fisher will release a new version of storage cap which has bevelled upper part to ease gripper and tube movements. Release is expected in a few months. |
| Contact Information |
1800 032 359 - Ortho-Clinical Diagnostics Customer Technical Services |