Events

Device Recall VITROS Performance Verifier II 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ortho Clinical Diagnostics Inc 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
    78724
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0807-2018
  • 사례 시작날짜
    2017-07-10
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160228
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • 원인
    Vitros performance verifier ii (pvii) lot k4852 does not meet long term stability requirements for the ast analyte (only) when the product is stored refrigerated for up to 6 months.
  • 조치
    On July 10, 2017 the firm sent notification letters and an e-communications to their customers. Foreign customers were notified by email. Customers were instructed to complete a response form with the amount of product on hand and to discontinue use of the recalled product. For further questions, please call (585) 453-3452.

Device

Device Recall VITROS Performance Verifier II
  • 모델명 / 제조번호(시리얼번호)
    Lot K4852, Expiration 22 Feb 2018
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide
  • 제품 설명
    VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. || Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
    Ortho Clinical Diagnostics Inc

Manufacturer

Ortho Clinical Diagnostics Inc
  • 제조사 주소
    Ortho Clinical Diagnostics Inc, 1001 US Highway 202, Raritan NJ 08869-1424
  • 제조사 모회사 (2017)
    The Carlyle Group LP
  • Source
    USFDA