Events

Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Seqirus 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-00817-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00817-1
  • 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
    The manufacturer merck-millipore has advised seqirus of an issue with anti-m monoclonal blood grouping reagents producing weak or negative testing results when testing m+ red blood cells in line with the method described in the instructions for use (ifu). seqirus sources these reagents as raw material items, which are then subject to acceptance testing and labelling / packaging and then distributed as seqirus epiclone anti-m. as part of batch release these materials passed all potency and specificity requirements, and there have not been any product technical complaints or market feedback of testing issues regarding these products.
  • 조치
    Seqirus is advising users to quarantine all affected stock from inventory. Seqirus will arrange collection of affected stock from customers.

Device

Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)Product Item Number: 00980501Pack Size: 1 unit per packLot Numbers: 009817001, 009817101 (exp 10/11/17), 009817201 (exp 11/11/17), 009817301, 009817401 (exp 09/12/19) and 009817501 (exp 05/12/19)ARTG: 225013
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd