Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Immucor 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
We are investigating a single instance of false positive reactivity of probe dqb253 associated with an allele
pair of dqb1*03:03:02:01, dqb1*03:04:01. a false positive result causes the exclusion of dqb1*03:03:02:01/
03:04:01 as a possible allele combination.
the risk to the patient is considered low due to the low frequency of this event, and the additional risk reduction
achieved through application of the requirements and limitations described in the product insert. results from
these kits are not to be used as the sole basis upon which a clinical decision affecting the patient is made. due
to the complex nature of hla typing, qualified personnel should review data interpretation and typing
assignments, as per the limitations of the procedure section of the product insert. .