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
System, colorectal neoplasia, DNA methylation and hemoglobin detection - Product Code PHP
원인
The diagnostic test kit may produce invalid test runs which may delay test results.
조치
Users were instructed to discontinue use of the kits, complete the acknowledgement form, and distribute the notification to relevant persons within organization. If kits were further distributed the consignee was asked to forward the safety notice to these entities.