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
Siemens healthcare diagnostics has confirmed that under very rare circumstances a false
negative result may be reportable.
the issue may only occur under the following conditions:
• the initial result is falsely flagged with an antigen excess error that triggers an automatic
remeasurement in a 1/19 dilution.
and
• the raw signal of the remeasurement is below the limit of blank (lob) of the method.
under such conditions the low remeasurement raw value may be strongly affected by the signal
noise of the optical system and can generate an erroneous low optical raw value. this raw value
will be corrected by the dilution factor and can be deduced from calibration curve in a false low
range. .