Liaison C-Peptid Assay. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00323-1

Class II

2017-03-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00323-1

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.

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.