U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Reagents, 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identific - Product Code OPU
원인
Firm has had an increasing number of customer complaints regarding higher than expected indeterminate test results due to "invalid" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens.
조치
Cepheid issued a notification to consignees regarding the affected product. Additional instructions were provided to consignees in order to avoid further "Indeterminate Results".
For further information, contact Cepheid at 1-888-336-2743.
Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
제품 설명
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. || Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.