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
The quality control criteria in the lmx product insert (pi) require lmnc to have a negative reported result for
all beads. therefore, a false positive result with lmnc invalidates the assay run, and requires the assay to be
repeated.
we recently identified that the negative control serum (lmnc lot 3003269, expiration date: 12-15-2017),
provided with lifecodes lifescreen deluxe (lmx) lot 3003351, may occasionally demonstrate false positive
reactivity. internal investigation identified this performance issue to be related to the interaction between
lmnc, lmx beads, and conjugate in this particular lot.
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