TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD) Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP 의 리콜

Recall

RC-2016-RN-00603-1

Class II

2016-05-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00603-1

Siemens healthcare laboratory diagnostics has confirmed that all in date lots of advia centaur tni-ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/ml (41 nmol/l). the instructions for use (ifu) states that specimens that have up to 10 ng/ml (41 nmol/l) of biotin demonstrate = 10% change in results. the biotin level in a general population is approximately 0.3 to 1.0 ng/ml (1.2 to 4.3 nmol/l).The biotin interference is proportionate across tni concentrations; therefore, the ability of the assay to detect serial increases or decreases of tni is maintained.

Siemens is advising users that the Tnl-Ultra assay can continue to be used, however, users should be aware that patients who are taking biotin supplements may exhibit a slightly elevated TnI-Ultra result; however, the ability of the assay to detect serial increases or decreases of TnI is maintained. A review of previously generated results is at the discretion of the Laboratory Director.