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 regret to inform you that in very rare cases a software (sw) malfunction in the sample&control datafile can
occur which may lead to a potential data mismatch. this sw malfunction only occurs:
∑ when the “sample data clear” function is not performed daily as indicated in the operator’s manual, and
∑ when the sample&control datafile of the elecsys 2010 analyzer is filled with > 600 records.
roche has received no customer complaints for this issue. this error only occurs if deletion of documented results
or samples is not performed as pre or post operation function.
.