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
in vitro diagnostic MRSA - Product Code NQX
원인
Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the xpert mrsa/sa bc (blood culture) product.
조치
On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.