Events

Instalert Multi‐Drug Multi‐Line Twist Screen Test Device and Instalert DOA Multi‐Drug Multi‐Line Screen Test Device, Saliva Collector 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Innovacon 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
    2013-06-25
  • 사례 출판 날짜
    2013-06-25
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130625a.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: instalert multi‐drug multi‐line twist screen test device and instalert doa multi‐drug multi‐line screen test device, saliva collector the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the saliva collector that is an accessory in the multi‐drug multi‐line twist screen test device and instalert doa multi‐drug multi‐line screen test device, manufactured by innovacon, inc. the affected kit lot numbers are doa3010115, doa3030337, doa3030682, doa3030529 and the affected lot numbers of the saliva collector are b121208, b130103, b130104, b130101. in certain lots, the sponge may become dislodged from the saliva collector handle prior to or during the oral fluid sample collection process. if the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk. the manufacturer's investigation indicates that the sponge may become dislodged on approximately 5% of the saliva collectors from affected lots. to date, there have been no reports of individuals swallowing or choking on the sponge during use. the manufacturer advises the affected users to: gently pull the sponge while it is in the wrapper before using the saliva collectors for the lots specified above and ensure it remains firmly attached to the handle; immediately discard any saliva collectors if the sponge detaches from the handle; and ask for a replacement product if they are not willing to perform the inspection steps. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con286923 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 june 2013.

Device

Instalert Multi‐Drug Multi‐Line Twist Screen Test Device and Instalert DOA Multi‐Drug Multi‐Line ...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Instalert Multi‐Drug Multi‐Line Twist Screen Test Device and Instalert DOA Multi‐Drug Multi‐Line Screen Test Device, Saliva Collector
  • Manufacturer
    Innovacon

Manufacturer

Innovacon
  • 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