Events

ARCHITECT Intact PTH Assay 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
    2014-02-14
  • 사례 출판 날짜
    2014-02-14
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140214.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 laboratories architect intact pth assay medical device manufacturer, abbott laboratories, has issued a field safety notice concerning certain lots of architect intact pth assay with list numbers: reagents (8k25-20, 8k25-25, 8k25-27), calibrators (8k25-01) and controls (8k25-10). the manufacturer has confirmed that a performance shift in the architect intact pth assay has the potential to generate falsely elevated results on patient samples. results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. the issue may also impact established architect intact pth reference ranges. abbott architect intact pth controls do not detect the shift. all current reagent, calibrator, and control inventory is impacted. falsely elevated patient results are generated when using the architect intact pth assay. the manufacturer advises users of the followings: to discontinue use of, and destroy, any remaining inventory of affected products; to continue intact pth testing at the laboratory, users should identify an alternate method for testing patient samples; and the field safety notice should be reviewed with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary. for non-enterobacteriaceae (quality control purpose), the mic shift over the time can be greater than +1 dilution when compared to the mics initially obtained at the time of the release. for enterobacteriaceae, the over-estimation of mic can change the category result of isolates having mic equal or close to the breakpoint. according to the manufacturer, this performance issue leading to this over-estimation of mic can be detected using the quality control as recommended in the etest package insert. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 february 2014.

Device

ARCHITECT Intact PTH Assay
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Abbott Laboratories ARCHITECT Intact PTH Assay
  • 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