Events

Optium Omega glucose test strips 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott Laboratories 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
    2011-01-11
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20110111.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
    Press release
  • 원인
    Resumption of sale of abbott's optium omega glucose test stripsthe department of health (dh) has today (january 11) agreed to allow one brand of abbott's glucose test strips, optium omega, to re-enter the market. a spokesman for dh said that the decision was based on consideration of information in hand, especially the differences in design and manufacturing of optium omega and the supply of alternatives on the market. dh, through its routine surveillance system, captured a us food and drug administration (fda) alert about the recall of over 380 lots, involving some 10 brands, of glucose test strips marketed by abbott diabetes care in the us late last december.? this is due to ineffectiveness of the strips - there are possibilities of obtaining falsely low blood glucose readings instead.? to allow time for proper investigation and as a precautionary measure to safeguard hong kong's public health, dh requested the local medical device supplier, abbott laboratories limited, to recall all its glucose test strips from consumers on december 29 last year. "as optium omega's unique design and manufacturing could ensure its exemption from ineffectiveness, dh thinks it reasonable to allow its re-entry into the local market, especially alternatives are not in abundance here in hong kong," a dh spokesman explained. "however, any time users are in doubt of the accuracies, they should stop using the strips and consult their healthcare providers," he further remarked. dh would continue to follow-up with the investigation and also closely monitor the recall of other brands of abbott’s glucose test strips. ends/tuesday, january 11, 2010.

Device

Optium Omega glucose test strips
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Resumption of Sale of Abbott's Optium Omega glucose test strips
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 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