Events

MIA FORA NGS HLA FLEX 11 KIT (24 tests). 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-01491-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01491-1
  • 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 made aware by the manufacturer, bioarray solution, that a limited number of mia fora ngs hla flex 11 kit (24 tests) ce kits lot 18- 107-11-c contain index adaptor plates (iap) p/n sr-800-00349, lot 18-30a that may result in incorrect calls for samples in the f1 and g1 plate positions due to switched barcode adaptors in positions f1 and g1. the impact of a defective iap when used for testing will result in the wrong call at plate positions f1 and g1 and therefore an incorrect result.
  • 조치
    Diagnostic Solutions is advising customers to quarantine all units of Lot 18-107-11-C from inventory. Diagnostic Solutions will confirm with users whether any of their stock is defective and will arrange for replacement of defective units. Diagnostic Solutions recommend that all F1 and G1 sample results generated with the MIA FORA NGS HLA FLEX 11 KIT (24 tests) Lot 18-107-11-C are retested to confirm samples have been correctly identified.

Device

MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD) Lot Number: 18-107-11-CARTG Number: 288368
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd