Events

Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Diagnostic Solutions Pty 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-2017-RN-00997-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00997-1
  • 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
    Diagnostic solutions has been informed by the manufacturer lmmucor gti diagnostics, that there is an error in the probe lot specific files and probe hit tables in the match it! dna 3.27.0 allele database update sent to customers in may 2017. the error impacts specific kits and lots numbers only.The error results in an incorrect typing for some non-common well defined alleles. however, the affected alleles are still correctly typed at low resolution.
  • 조치
    1. Complete the supplied response form. If any of the affected stock could have been transferred from your Laboratory to another, please immediately forward a copy of this letter to relevant staff. 2. Retain this letter in a prominent position until the database is updated. 3. A representative from Diagnostic Solutions will be in contact with users as soon as the database update is available. 4. Consider re-analysing the data once the database update is made.

Device

Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical devi...
  • 모델명 / 제조번호(시리얼번호)
    Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD)HLA-DRB1 SSO Typing KitSupplier Code: 628923Lot Numbers: TL628923 and TL628923sLot Numbers: 04226A and 11125AHLA-DQA1/B1 SSO Typing Kit Supplier Code: 628930Lot Numbers: TL628930, TL628930s and TL628930pLot Numbers: 3004970, 06306A and 10205AARTG Numbers: 217874 and 217873
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd