Events

VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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-00648-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00648-1
  • 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 has become aware of the potential of an inability to obtain a valid calibration when using vitros afp reagent packs.Ortho clinical diagnostics (ortho) confirmed that the affected lots exhibited an increase in reaction signal over time. the investigation indicates that there is the potential for sample concentrations to increase during the 28-day calibration timeframe by up to 12% and that the magnitude of the positive bias will decrease as sample concentrations increase. there have been no reports of injuries as a result of this issue.
  • 조치
    Ortho Clinical is advising users to discontinue use and discard affected lots. If users are able to successfully calibrate and QC results are acceptable, users may continue to use the affected lots until the replacement stock arrives. Previously reported results are valid, providing that QC results were within acceptable limits. This action has been closed out on 13 Jun 2017.

Device

VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medica...
  • 모델명 / 제조번호(시리얼번호)
    VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD)VITROS AFP Reagent PackDevice Identifier: 10758750006489Product Code: 1925551VITROS AFP CalibratorsDevice Identifier: 10758750006540Product Code: 1515154Lot Number: 1470Expiry Date: 13 Dec 2016ARTG Number: 248385
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics