Events

Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abacus ALS 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-00101-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00101-1
  • 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
    A malfunction of elia anti-tsh-r well carriers 14-5639-01 in lot 0014 has been discovered. the specified lot includes a limited number of carriers, where 8 or 16 wells in sequence will produce decreased response units (ru). out of 4122 carriers, to date 12 carriers have been identified giving this low ru pattern.To date, no adverse events have been reported. in australia these kits are currently used for evaluation purposes, not for generating patient results.This recall does not affect any other lots of elia anti-tsh-r or any other phadia products.
  • 조치
    Abacus ALS is advising affected users to quarantine any affected stock of the specified lot and discontinue use.

Device

Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device
  • 모델명 / 제조번호(시리얼번호)
    Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical DeviceLot Number: 0014.Abacus ALS part number: PU14563901, Manufacturers part number: 14-5639-01ARTG Number: 229585 (Abacus ALS Pty Ltd - Clinical chemistry autoimmune IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd