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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00323-1
Product Name/Description	Liaison C-Peptid Assay. An in vitro diagnostic medical device (IVD). Part Number: 316171 All Lots ARTG Number: 189435
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/03/2017
Responsible Entity	DiaSorin Australia Pty Ltd
Reason/Issue	A recent testing of Liaison C-Peptid assay by DiaSorin has highlighted the issue of cross reactivity with human proinsulin. This cross reactivity occurs in 100% of the tested samples and results in an increased C-peptide concentration in all samples tested, across all populations. For normal patients, the risk of falsely elevated results is rare, since the concentration of proinsulin in healthy fasting people is at least 100 times lower than the C-peptide concentration and therefore has only minimal effect on the results determined with the assay. Patient populations of highest risk for falsely apparently elevated assay results are patients with insulin processing defects, renal malfunction, insulinoma or similar conditions.
Recall Action	Recall for Product Correction
Recall Action Instructions	DiaSorin is requesting users to confirm receipt of the “Urgent Recall for Product Correction” notification by completing the response section and returning it to DiaSorin. Users are advised of the possibility of further action pending TGA's receipt of additional information. This action has been closed-out on 23/03/2018.
Contact Information	02 9338 4859 - DiaSorin Australia