ADVIA CENTAUR (CP) SYSTEM-TROPONIN I ULTRA (TNI-ULTRA)… — recall 55361
Health Canada — Medical Devices · Canada · 2016-05-24 · Type III
As described by Health Canada — Medical Devices: ADVIA CENTAUR (CP) SYSTEM-TROPONIN I ULTRA (TNI-ULTRA) ASSAY(2016-05-04)
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Archived by the issuing authority — kept for reference
Reported risk: An urgent field safety notice (UFSN) has been issued by Siemens informing the customers of the biotin interference in the ADVIA Centaur TnI-Ultra assay. 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 states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin demonstrate =10% change in results.
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