VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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-01008-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-10
  • 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
    Ortho clinical diagnostics (ortho) determined that the unopened storage condition for vitros performance verifier ii, lot k4852 requires revision when using vitros chemistry products ast slides or vitros chemistry products astj slides.The instructions for use (ifu) states that unopened vitros performance verifier ii can be stored either frozen until the expiration date or refrigerated for =6 months. stability testing determined that unopened vials for lot k4852 did not meet the product’s 6 month specification when stored refrigerated. all other lots are not affected.Product that is stored frozen is not affected by this issue. customers can continue to use frozen-stored product through its expiration date.
  • 조치
    Ortho Clinical Diagnostics is requesting customers: 1. Be aware that unopened vials of Lot K4852 can no longer be stored refrigerated to verify the performance of VITROS AST or ASTJ Slides; 2. Discard any remaining inventory stored refrigerated if used to verify VITROS AST or ASTJ Slides; and 2. Retain this notification as verification of the revised instructions. Complete the Confirmation of Receipt form supplied with the customer letter and return by August 15th, 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)Product Code (Unique Identifier): 8231474 (10758750004577)Lot Number: K4852Expiry: 22 Feb 2018
  • Manufacturer

Manufacturer