LeadCare Testing Systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Magellan Diagnostics 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

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.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2017-05-18
  • 사례 출판 날짜
    2017-05-18
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: magellan diagnostics leadcare testing systems the united states food and drug administration (fda) has issued a medical device safety alert concerning leadcare testing systems, manufactured by magellan diagnostics. the fda is warning facilities such as laboratories or health clinics that magellan diagnostics’ leadcare testing systems may underestimate blood lead levels (blls) and give inaccurate results when processing venous blood samples. the fda is providing recommendations to help mitigate the risk of inaccurate test results to assure that patients receive accurate information regarding potential lead exposure. the fda is also strongly urging parents and at-risk adults to speak with their health care provider about the u.S. centers for disease control’s (cdc) recommendations on re-testing. the cdc recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested. the fda recommends laboratories and health care professionals take the following actions: discontinue using magellan’s’ leadcare system testing systems with venous blood samples. at this time, all leadcare systems can be used with capillary blood samples. report any adverse events to the fda and to magellan diagnostics. if laboratories or health care professionals are concerned about using the leadcare test systems, the alternative options are mass spectrometry or atomic absorption methods. these are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs. this safety communication replaces all previous communication from magellan diagnostics on their leadcare lead testing systems including magellan’s most recent field safety correction notification dated april 28, 2017. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm558988.Htm https://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm558733.Htm https://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm558769.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Magellan Diagnostics LeadCare Testing Systems (Update)
  • Manufacturer

Manufacturer