Events

Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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
    RC-2015-RN-00401-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00401-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics has confirmed that the immulite 2000/immulite 2000 xpi italian cypress allergen lot 206 does not meet the shelf-life stability as indicated on the label. this may lead to single class change decrease (standard classification) in patient results across the current shelf-life of this allergen lot. patient dose values may decrease before the stated expiry date listed on the allergen vial.It is expected that lot 208 will also not meet its current shelf life stability and must be discarded after june 30, 2015.
  • 조치
    Siemens is requesting laboratories to discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen from lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Laboratories are requested to discontinue use and discard lot 208 after June 30, 2015.

Device

Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen
  • 모델명 / 제조번호(시리얼번호)
    Immulite 2000 and Immulite 2000 XPi – Italian Cypress AllergenSiemens Material Number: 10386079Lot Numbers: 206 and 208ARTG number: 198420
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division