A field safety notice
was also registered for the hydrosurgery device due to its manufacturing error in reported headpieces.
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.
As a result of these three reports, Haag-Streit issued a 'Field Safety Notice
' (FSN) in October 2008 to all its customers--included in the FSN is a field test for clinicians to check the tonometer prism for cracks and scratches.
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.
Siemens sent an Urgent Field Safety Notice
, dated August 21, 2013, to all affected customers.