Events

ARCHITECT STAT High Sensitive Troponin-I Assay 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
    2016-05-03
  • 사례 출판 날짜
    2016-05-03
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160503.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 stat high sensitive troponin-i assay medical device manufacturer, abbott, has issued a medical device safety alert concerning its architect stat high sensitive troponin-i assay. the manufacturer is informing affected users of a product recall and reduced expiration dating for select architect stat high sensitive troponin-i reagent lots. predictive quality assurance monitoring of architect stat high sensitive troponin-i reagent lots was initiated following the field action that occurred in january (fa21jan2016). as a result, the manufacturer has identified a potential for increased calibration failures prior to the expiration date. according to the manufacturer, there is a potential for delay in results due to calibration errors and failure to calibrate. nonetheless, there is no impact to generated patient results. manufacturer will continue to monitor performance of all on-market lots. until root cause is determined and corrective actions are implemented, new reagent lots will have a proactively shortened expiration date of 4 months from date of manufacture. the expiration date will require adjustments to the laboratory inventory and order management practices. affected users are instructed either: to destroy any remaining inventory of affected lots once an alternate reagent lot is available, or to adjust the expiration date of the affected lots 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 3 may 2016.

Device

ARCHITECT STAT High Sensitive Troponin-I Assay
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Abbott ARCHITECT STAT High Sensitive Troponin-I Assay
  • 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