Events

Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abacus dx 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-2018-RN-00283-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-04-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00283-1
  • 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
    Abacus has been advised by immucor (the manufacturer), that as a result of a complaints investigation, it has been determined that the serological group for the b*27:08 allele was incorrectly assigned as bw4. the correct serological group assignment for b*27:08 is bw6. this assignment was part of the 3.29.0 allele database update. immucor confirm that there is no impact to the lifecodes hla-b sso typing kits themselves.Abacus technical support has confirmed that australian customers do not currently utilise this component of the software, however, are rectifying the issue so it does not present a hazard in the future.
  • 조치
    Abacus dx is advising that Immucor has created an executable file to correct the serological group assignment for B*27:08 when using the s.29.0 database update, which is available on the Immucor website. Customers are asked to upload this executable file before running LIFECODES HLA-B SSO typing kits. Instructions for uploading this file to correct the serological group alignment are outlined on the Customer Letter.

Device

Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database...
  • 모델명 / 제조번호(시리얼번호)
    Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.LIFECODES HLA-B SSO Typing Kit Affected Lots: 01117A (exp 30/11/2018) and 06036A (exp 31/05/2018)Typing Kit Catalogue Numbers: TL628915 and TL628915sARTG Numbers: 257272 , 217871
  • Manufacturer
    Abacus dx Pty Ltd

Manufacturer

Abacus dx Pty Ltd