Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Randox 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
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.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
데이터 추가 비고
원인
We are currently investigating an issue with the products listed below and are providing this urgent
field safety notice to inform you of this occurrence.
detail on affected devices: immunoassay control ia2640 lot 1364ec and immunoassay
premium plus control ia3112 batch 334337 lot 1364ec.
description of the problem: pth stability has been reduced in control lot 1364ec. it is now
recommended that pth is tested immediately after reconstitution.
risk to health: the contents of this letter should be discussed with your medical director. it is
unlikely the error will cause misreporting of patient results as values for pth using this lot would fall
outside of the assigned ranges. .