| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01233-1 |
| Product Name/Description |
FerriScan (software for determining liver iron concentration from MRI images)
Reports with LIC > 43 mg/g of dry tissue and issued between 5 Oct 2105 to 26 Aug 2016
ARTG Number: 116071 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that there is a misprint in the Liver Iron Concentration (LIC) measurement units on a subset of FerriScan Reports. The report should include the Average Liver Iron Concentration result in mg/g dry tissue on the first line of the report and in mmol/kg dry tissue on the second line. This misprint only affects the second line result, where mg/g dry tissue is displayed rather than the correct units of mmol/kg dry tissue. The correct value (number) is displayed. The first line has both the correct value (number) and correct measurement units.
An investigation by Resonance Health determined that the misprint only occurred in specified reports where the LIC value was greater than 43 mg/g of dry tissue. As such, the misprint for the second line result only occurs in cases of extreme liver iron overload. No other reports are affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Resonance Health is advising those with affected reports of the error in the measurement units and will re-issue reports on the request of users. This action has been closed-out on 10/05/2017. |
| Contact Information |
08 9286 5300 |