| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01010-1 |
| Product Name/Description |
m24sp Instrument System (sample extraction system). An in vitro diagnostic medical device (IVD)
List Number: 03N06-01
ARTG Number: 206870 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Molecular has identified that when duplicate sample IDs are used for multiple replicates of a sample, calibrator or control in the same run: some samples may not be included in the Plate Report; some duplicate sample IDs are reassigned a unique identifier by the software and a warning message is displayed in the Plate Report. These issues occur if duplicate sample IDs are used within a run, on the m24sp Plate Report. The m24sp Plate Report is a PDF file generated by the software for each instrument run. It provides a list of sample ID’s and their processing information and error status. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott Molecular is advising users that to ensure proper function of the Plate Report, duplicate sample IDs should not be used on the m24sp. If two or more replicates of a sample, calibrator or control are being run, a unique sample ID should be used for each of the replicates. This action has been closed-out on 15/07/2016. |
| Contact Information |
02 9857 1098 - Abbott Diagnostics |