Events

Device Recall VITROS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 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
    61222
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1316-2012
  • 사례 시작날짜
    2012-02-02
  • 사례 출판 날짜
    2012-03-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107602
  • 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
    Ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl - Product Code LBS
  • 원인
    Ortho clinical diagnostics (ocd) has revised the vitros dhdl slides instructions for use (ifu) and removed edta plasma as a recommended sample type.
  • 조치
    Ortho Clinical Diagnostics sent an Important Product Information letter dated February 2, 2012, to all affected customers via Federal Express overnight mail. The letter informed customers of the issue, notifying them of the removal of EDTA plasma as a recommended sample type and providing the revised VITROS¿ dHDL Slides Instructions for Use. J&J; Foreign affiliate consignees were notified by email informing them of the issue on 02 February 2012. Customers were instructed to replace the current pages in their VITROS Chemistry Products Instructions for Use Manual with the updated instructions for Use and Table of Contents. Customers were asked to return the enclosed Confirmation of Receipt form regardless of whether their laboratory uses the affected product. For any questions regarding this recall call 1-800-421-3311.

Device

Device Recall VITROS
  • 모델명 / 제조번호(시리얼번호)
    all lots
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson; company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count) --- indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • 제조사 모회사 (2017)
    The Carlyle Group LP
  • Source
    USFDA