Events

Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 bioCSL 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-2015-RN-01146-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-11-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01146-1
  • 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
    This product is a 3 cell screening panel that is used in immunohematology testing to screen patient plasma or serum samples for the presence of clinically relevant red cell alloantibodies for pre transfusion and pre-natal testing.Cell 2 when tested against weak anti e controls (i.E. securacell) during pre-acceptance testing in biovue and grifols cat platforms, is giving weak or negative reactions and not the expected mid-strength reactions. however, testing in the bio-rad (diamed) cat platform is giving the expected result.There is a potential risk that undetected weak anti-e antibody using certain cat platforms could lead to delayed hemolytic transfusion reactions (dhtr) for the patient.
  • 조치
    The sponsor Seqirus is advising the users to inspect stock and quarantine all affected units prior to their return. The sponsor will arrange the replacement of the affected units or return credit. This action has been closed-out on 29/08/2016.

Device

Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)Abtectcell III% 0.8%Item Number: 22450201Lot Number: 2245204Expiry Date: 26/12/2015Abtectcell III% 0.8% Bulk PackItem Number: 22450205Lot Number: 2245204AExpiry Date: 26/12/2015ARTG Number: 223867
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd