Events

First Response Digital Pregnancy Test and First Response Test & Reassure. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Church and Dwight Australia 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-00212-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-02-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00212-1
  • 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
    It has been determined that during consumer use, the internal mechanism of the affected devices is giving an error reading which is shown as "?" on the display. there are no health risks associated with this issue; the device will not give a false positive or false negative result reading.
  • 조치
    Church & Dwight is advising wholesalers to inspect their stock and quarantine affected stock to prevent further sale. Affected stock is to be returned to Cargo Line International. Wholesalers are requested to provide a copy of the recall letter to other warehouses, retail facilities or other organisations to which they have transferred or supplied affected product. Consumers will be provided a full refund, from where they purchased the product or by contacting Church & Dwight Customer Service, for devices from the affected batches that have resulted in an invalid (“?”) reading. This action has been closed-out on 23/06/2017.

Device

First Response Digital Pregnancy Test and First Response Test & Reassure. An in vitro diagnostic ...
  • 모델명 / 제조번호(시리얼번호)
    First Response Digital Pregnancy Test and First Response Test & Reassure. An in vitro diagnostic medical device (IVD).First Response Digital Pregnancy Test Product Code: 0734Lot Numbers: SU5341 (exp 07/2017), SU6207, SU6237, SU6305A (exp 07/2017), SU6308 (exp 10/2017), SU6335 (exp 10/2017)First Response Test & ReassureProduct Code: 0737Lot Numbers: SU6196 (exp 07/2017), SU6315A (exp 10/2017)ARTG Number: 231933
  • Manufacturer
    Church and Dwight Australia Pty Ltd

Manufacturer

Church and Dwight Australia Pty Ltd