ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00180-1

Class II

2016-02-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00180-1

Siemens healthcare has confirmed a lot to lot bias with calibrator e for the advia centaur testosterone assay. siemens’ internal investigation demonstrates:· an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42. · an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43. · the positive bias of lots ending in 42 to the master curve compared to the negative bias of lots ending in 43 to the master curve is the main driver for the negative bias between values generated with lots ending in 42 and 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the risk to health as a result of this issue is negligible. the biases observed across the assay range would not impact clinical management of patients being evaluated for androgen disorders or chemical castration.

Siemens is advising users that Calibrator E with lots ending in 42 and 43 can continued to be used to calibrate Testosterone on the Centaur CP system. Lots ending in 44 and above should be used for other Centaur systems. A review of previously generated results due to this issue is at the discretion of the laboratory.