현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
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The manufacturer's internal testing has determined that, if the user adheres to the instruction manual that provides the specified pipetting order and the "carryover" logic specified in the user manual for ilab 600/500 and the user manual for ilab taurus, the values obtained for magnesium could be higher than expected. the problem was found to be in carryover, that is, in transferring the reagent between the two analyzes, which is lagging behind on the needle, when the magnesium test is performed as part of a routine job.