Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel.
Description du dispositif
CellSearch Circulating Tumor Cell Kit (Epithelial) IVD || REF 7900001 || Veridex LLC, a Johnson & Johnson Company.