Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High Range 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Taylor Bio-Medical 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-2016-RN-01270-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-23
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 typographical error has been identified in certain quantum blue calprotectin assay kits. the printed expiration date on the labelling of the kits is incorrect. the correct expiry date is 2016-dec-31. there is no risk to health if the assay kits are used by this date.
  • 조치
    Taylor Biomedical has advised customers to check if they have affected stock. Customers will be requested to include in the affected stock, an advisory notice with details of the correct expiry date. This action has been closed-out on 28/11/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High RangeQuantum Blue Calprotectin AssayLot Numbers: 2930N Expiry: 2017-July-31Quantum Blue Calprotectin High RangeLot Number: 2930N.HR Expiry: 2017-April-30
  • Manufacturer

Manufacturer