Events

Clinical Chemistry Alkaline Phosphatase Reagent 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott 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
    2011-08-30
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110830.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
    Product recall: abbott diagnostics clinical chemistry alkaline phosphatase reagent abbott diagnostics (abbott) has issued an urgent product recall on clinical chemistry alkaline phosphatase reagent lots 71628un10, 62474un10, and 08145un11, due to particulate matter in some reagent cartridges, which has been identified as a cladosporium fungal species. according to abbott, the fungus does not represent a hazard, but appears to generate visible clumps within the reagent cartridge, and may cause discoloration over time. abbott supplemented that they have not received reports of inaccurate alkaline phosphatase results due to this issue, nor has internal testing demonstrated any impact to results; however, having confirmed the error codes on calibration and sample runs, internal data suggests a rare (0.00636%) potential for inaccurate results to exist. the supplier suggests that, if you are using or have inventory of clinical chemistry alkaline phosphatase (ln 7d55-21 lot 71628un10, or ln 7d55-31 lot 62474un10 and/or lot 08145un11), you should discontinue use and destroy any remaining inventory of those lots in accordance with your institution’s policies and procedures. according to the local supplier, the affected products have been distributed in laboratories in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Clinical Chemistry Alkaline Phosphatase Reagent
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: [30 Aug 2011] Abbott Diagnostic Clinical Chemistry Alkaline Phosphatase Reagent
  • Manufacturer
    Abbott Diagnostics

Manufacturer

Abbott Diagnostics
  • 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