Search Results for blood collection

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FDA Finalizes Chagas Disease Guidance for Blood Collection Establishments By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the use of serological tests to reduce the risk of transmission of T. cruzi, a parasite that causes Chagas Disease, in blood and blood components.

Categories: News, US, CBER, Blood, Compliance

Tags: Chagas Disease, blood collection, FDA guidance

Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device By Zachary Brennan - Published 24 May 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning lettter for Maryland-based Qiagen over deficiencies with its blood test used for diagnosing tuberculosis (TB), noting multiple complaints for high false positive rates.

Categories: News, US, FDA, Manufacturing, Medical Devices, Postmarket surveillance

Tags: Qiagen, TB test device, blood collection medical device, warning letter