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 - Product Code NQI
원인
An increased incidence of aggregates was observed in lot 0036 and 0036a. the presence of aggregates will cause customers to invalidate patient results.
조치
All Direct customers and customers of distributors received a customer notification informing them of the increased incidence of aggregates in cartridges on April 30, 2007 by Fed Ex overnight. This letter instructed them to discontinue use and to discard any remaining inventory.
This was followed by a notification on May 24, 2007 by Fed Ex overnight to all US Distributors which also requested that they immediately stop using and/or distributing kits and to destroy any remaining inventory. Distributors were also asked to notifiy customers who received product. All foreign affiliate consignees were also informed on this date by e-mail and instructed to notify their customers.
The kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J; affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.
제품 설명
Cell Search Circulating Tumor Cell Kit (Epithelial) || Veridex LLC, a Johnson & Johnson Company || IVD || Veridex, LLC || 33 Technology Drive || Warren, NJ 07059 USA || 1-877-VERIDEX USA