Events

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
    2010-12-23
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20101223.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
    Recall of abbott's glucose test stripsthe department of health (dh) has directed local supplier abbott laboratories limited to recall 359 lots of glucose test strips which may give falsely low blood glucose results today (december 23). the recall followed assessment of a us food and drug administration (fda) alert, captured by dh's routine surveillance system, which involved the recall of 359 different lots of glucose test strips marketed by abbott diabetes care in the us under the following brand names: * precision xceed pro; * precision xtra; * medisense optium; * optium; * optiumez; and * relion ultima the blood glucose monitoring systems are not affected by this recall. more details of the recall are posted under fda news (medical devices) and the abbott diabetes care respectively: http://www.Fda.Gov/newsevents/newsroom/ pressannouncements/ucm237900.Htm http://www.Precisionoptiuminfo.Com/img/lot-numbers.Pdf according to initial information from the local supplier, at least the following items and lot numbers in the list of test strips are available in hong kong: medisense optium blood glucose electrodes * lot 45001a137 * lot 45001a921 precision xceed pro blood glucose test strips * lot 44cr5h abbott's records revealed that some 6,000 boxes of the above lots are available in hong kong. a spokesman for dh said although records showed that only three lots were shipped to hong kong, it was necessary to recall all 359 lots of products as some products might have been directly brought back to hong kong by consumers or purchased over the internet. so far, the dh has not received any report of adverse events arising from the affected products. members of the public should stop using any of the 359 lots of products and contact healthcare professionals if in doubt. they may contact the company at hotline 2806 4488 daily from 9am to 5pm for recall arrangements. hospitals, medical associations and nursing homes have been alerted. the department will closely monitor the recall. investigation continues.   thursday, december 23, 2010.

Device

glucose test strips

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