Events

ARCHITECT Active-B12 Reagent Kit 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott 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
    2016-12-02
  • 사례 출판 날짜
    2016-12-02
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161202.html
  • 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: abbott architect active-b12 reagent kit medical device manufacturer, abbott, has issued a medical device safety alert concerning its architect active-b12 reagent kit. the affected devices are identified as follows:- list number: (i) 3p24-25, (ii) 3p24-35 lot number: (i)10533up00, (ii)10534up00 udi number: (i) [(01) 00380740006365, (17) 170529, (10) 10533up00, (240) 3p2425] (ii) [(01) 00380740006372, (17) 170529, (10) 10534up00, (240) 3p2435] expiration date: 29 may 2017 the manufacturer has identified a lot specific stability issue with both reagent lots 10533up00 and 10534up00. as the reagent ages, relative light unit (rlu) values for the calibration curve will decrease causing patient results calculated from this depressed curve to over-recover, potentially resulting in falsely elevated patient results. controls may not reflect reagent instability as recalibration may result in control values within acceptable ranges. there is a potential for falsely elevated active-b12 results to be generated when using architect active-b12 reagent lots 10533up00 and 10534up00. internal studies have determined the worst case magnitude of elevation to be up to 30% for active-b12 concentrations close to 20 pmol/l and up to 20% for concentrations close to 30 pmol/l. affected users are instructed to discontinue use and immediately destroy any remaining inventory of architect active-b12 reagent lots 10533up00 and 10534up00 and order replacement material. they should also review the information with their medical director to determine if a review of results previously generated with reagent lots 10533up00 and 10534up00 is required. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 december 2016.

Device

ARCHITECT Active-B12 Reagent Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Abbott ARCHITECT Active-B12 Reagent Kit
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH