Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2018-RN-00109-1

Class II

2018-02-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00109-1

The manufacturer, ibl has detected an issue that indicates a degradation in performance of the kit resulting in elevated cortisol values. when testing patient samples with one of the affected lots, the controls and calibrator values will meet specifications; however, due to a degradation in the starting concentration of the calibration standards, the calculated results for individual patient samples may be higher compared to lc-ms/ms measurements and may trigger unnecessary additional testing.A review of additional data comparing the respective kit standards of the lots to lc-ms/ms data it is evident that the lots eco142 to eco143 generate elevated results:- eco142 (passing bablok fit (y=0.009988 + 1.549x)- eco143 (passing bablok fit (y=0.003142 + 1.623x)there has not been any reports of injuries associated with this issue.

Abacus is advising users to inspect stock and quarantine any remaining stock of the affected batches. Affected product will be replaced with unaffected stock. A review of previously generated patient results is at the discretion of the Laboratory Director.