Missed detection of significant positive and negative shifts in gentamicin assay: implications for routine laboratory quality practices

摘要

IntroductionA product recall was issued for the Roche/Hitachi Cobas Gentamicin II assays on 25^th May 2016 in Australia, after a 15 - 20% positive analytical shift was discovered. Laboratories were advised to employ the Thermo Fisher Gentamicin assay as an alternative. Following the reintroduction of the revised assay on 12^th September 2016, a second reagent recall was made on 20^th March 2017 after the discovery of a 20% negative analytical shift due to erroneous instrument adjustment factor.