| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00175-1 |
| Product Name/Description |
Abbott Molecular m 2000sp instrument. An in vitro diagnostic medical device (IVD)
List Number: 09K14
This issue is not serial number specific |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.
This recall action was not notified to the TGA before it was initiated by Abbott Australasia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott is providing work around instructions to mitigate the issue temporarily. The issue will be corrected in the next version of the m2000sp software which will be available by the end of first quarter 2013. |
| Contact Information |
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