Calibrator E used for calibration of the ADVIA Centaur Systems Cortisol, Progesterone and Testosterone assays 의 리콜

Recall

RC-2014-RN-01060-1

Class III

2014-10-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01060-1

Siemens healthcare diagnostics has identified a positive bias for calibrator e kit lots ending in 38 and 39 with the advia centaur systems cortisol and progesterone assays compared to the respective master curves. patient serum samples evaluated with the advia centaur cortisol assay and calibrated with affected lots of calibrator e kit demonstrate an average positive bias of 16% across the assay range with a maximum bias of 28%. patient serum samples evaluated with the advia centaur systems progesterone assay and calibrated with affected lots of calibrator e kit demonstrate a positive bias with samples above 30 ng/ml. the average positive bias on the advia centaur/advia centaur xp is 20% with a maximum bias of 39%. the average positive bias on the advia centaur cp is 17% with a maximum bias of 35%.The advia centaur systems testosterone assay is not affected by this correction.

Siemens is notifying their customers of the potential for positive bias when using the affected calibrators. As the bias only occurs outside of the useful clinical range the calibrators can continue to be used. Unaffected calibrators can be ordered if required. This action has been closed-out on 01/03/2016.