Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Thermo Fisher Scientific 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
On august 22, 2016 we sent you the below notice on the qms® everolimus immunoassay.
since this letter was sent to you additional information has come to light regarding patient
samples. originally in the “reason for field action” section we reported that
“current patient samples are not in question.” thermo fisher wishes to update that
statement to the following: “you may observe bias in patient samples ranging from -15.7%
to +5.2% with an average bias of -5.6% when comparing your assay to the lc-ms reference
method”.
additionally, thermo fisher is also updating the “risk to health” section. the update
clarifies that all ranges (sub-therapeutic, therapeutic, supra-therapeutic) may be affected by
as much as 16%. .