Simplexa™ HSV 1 & 2 Direct
Simplexa™ Flu A/B & RSV Direct
Simplexa™ Group A Strep Direct 에 대한 현장 안전성 서한
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Focus Diagnostics 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
Focus diagnostics has received customer complaints regarding mol2150 and mol2650 kits.
two issues have been reported:
1) first with early cycle threshold (ct) in the sample wells of the direct amplification
discs (mol1455, mol1452, mol1451) while performing the mol2150 and
mol2650 testing (see figure 1 for some examples of early ct). this error may result
in a false negative result, a false positive result or error code(s) 500 or 505.
2) additionally, some customers are reporting insufficient specimen volume errors
which may result in higher invalid rates. in those cases, the error results in a report
note statement of “insufficient specimen volume”.
.