field safety notice

field safety notice

A term defined by the European Commission DG Enterprise and Industry as a communication to customers and/or users, sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action (see there).
References in periodicals archive ?
In the same year, laboratory professionals received an urgent field safety notice related to more than 20 lot numbers of a troponin I immunoassay which showed >10 percent change in results for samples with biotin levels [less than or equal to]10 ng/mL; this was inconsistent with the product's instructions for use.
updating the label with new user warnings), new supply will be permitted, provided that such supply is accompanied by the product owners field safety notice (FSN), which is a notice the owners send to device users in relation to the FSCA.
New definitions of existing concepts, Field Safety Corrective Action (FSCA), Field Safety Notice, use error and abnormal use are introduced and will be discussed further later in this column.
There is no surprise here, but the FSCA needs to be reported in the Field Safety Notice template form provided in Annex 4, Report Form: Field Safety Corrective Action.
Siemens sent an Urgent Field Safety Notice, dated August 21, 2013, to all affected customers.