안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
데이터 추가 비고
Abbott Laboratories is working to speed up product replacement. ///////// NOTE: Are all results between 0.5 and 2.0 ng / mL suspect? - No, only some apparently healthy patients can show results between 0.5 and 2.0 ng / ml. Consider that for the diagnosis in myocardial infarction, an initial result of AxSYM TROPONINE - I Reagent. Lot: 90172M300, should be analyzed in conjunction with other cardiac markers (CK-MB, Myoglobin), ECG, symptoms and signs, etc.
원인
Possible increase in the frequency of results above 0.5 ng / ml (from 0.6 to 2.5 ng / ml) in apparently healthy patients. these results, initially above 0.5 ng / ml, once retested present results below 0.5 ng / ml. this possibility was not observed in patients with a confirmed diagnosis of acute myocardial infarction.
조치
Discontinue use of AxSYM TROPONIN - I Reagent. Lot: 90172M300.