| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00708-1 |
| Product Name/Description |
m24sp Instrument System (sample extraction system). An in vitro diagnostic medical device (IVD)
List Number: 03N06-01 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Molecular has identified that the System Liquid sensor and Liquid Waste sensor on the m24sp Instrument System may be disabled due to an issue with the m24sp Application Database. If the System Liquid sensor and Liquid Waste sensor are disabled, users will not be notified by the m24sp that the System Liquid container needs to be filled or that the Liquid Waste container needs to be emptied. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that if they follow the Daily Maintenance and Operating Instructions within the m24sp Operations Manual there will be no impact as the containers are large enough to hold sufficient amounts of system liquid and liquid waste for daily use. A Field Service Representative will ensure that the System Liquid and System Waste sensors are enabled during installation of Application Database version 7.0. |
| Contact Information |
1800 816 696 - Abbott Customer Support |