Events

Quantiferon (QFT) Gold Tubes, QFT Gold Unitised Pack, TB Ag Tubes 100ct, QFT Gold Tubes (Nil & TB & Mitogen) High Altitude. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Cellestis 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
    RC-2012-RN-01065-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-10-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01065-1
  • 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
    Reports of higher than expected rate of quantiferon (qft) tb gold positive results from lot # a111103n have been received; cellestis initiated an investigation into the situation and confirmed the findings with the identification of 4 positive results from 17 persons who tested negative using several other lots of tubes. cellestis conducted a review of the manufacturing process and identified the potential contamination of lot # a111103m (high altitude) and a portion of tubes from lot #a111103m.This recall action was not notified to the tga before it was initiated by cellestis ltd.
  • 조치
    The sponsor is asking all user to discontinue use and dispose of current stock. Customers are advised that is unexpected positive results have been obtained using the affected tubes, results should be considered in light of all clinical information. Patient re-testing using a different Lot of QFT TB-Antigen tubes should be considered. If a re-test is required, Cellestis will provide a replacement.

Device

Quantiferon (QFT) Gold Tubes, QFT Gold Unitised Pack, TB Ag Tubes 100ct, QFT Gold Tubes (Nil & TB...
  • 모델명 / 제조번호(시리얼번호)
    Quantiferon (QFT) Gold Tubes, QFT Gold Unitised Pack, TB Ag Tubes 100ct, QFT Gold Tubes (Nil & TB & Mitogen) High Altitude. An in vitro diagnostic medical device (IVD).QFT Gold TubesProduct Number: 0590-0201Lot Number: 059080251QFT Gold Unitised PackProduct Number: T0597-0403Lot Number: 059780251TB Ag Tubes 100ctProduct Code: T0592-0201Lot Number: 059280281QFT Gold Tubes (Nil & TB & Mitogen) High Altitude (HA)Product Code: T0590-0505Lot Number: 059090081
  • Manufacturer
    Cellestis Ltd

Manufacturer

Cellestis Ltd