Events

Device Recall Optilite IgG4 Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The Binding Site Group, Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    76131
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1089-2017
  • 사례 시작날짜
    2016-12-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152264
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
  • 원인
    A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert.
  • 조치
    Customer notification letters were sent on 12/23/16. The Binding Site recommends to continue testing on the kit as normal and refer to the measuring ranges and limit of quantification stated in the notice and as indicated in the amended insert (INS009.OPT.A, Version: 21st December 2016) provided with this notification. The notice needs to be passed on to all those who need to be aware within the organization or to any Organization where the potentially affected devices have been transferred. Return the completed E-Back Form to your local Binding Site Representative for records and note that The Binding Site intends to report this correction to the FDA recall coordinator. If you have any questions contact Technical Services.

Device

Device Recall Optilite IgG4 Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot #401413
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
  • 제품 설명
    Optilite IgG4 Kit || Product Code: LK009.OPT.A
  • Manufacturer
    The Binding Site Group, Ltd.

Manufacturer

The Binding Site Group, Ltd.
  • 제조사 주소
    The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
  • 제조사 모회사 (2017)
    Cidron Iugo Sarl
  • Source
    USFDA