Events

VITROS 5,1 FS Chemistry System 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
    70918
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1728-2015
  • 사례 시작날짜
    2015-04-06
  • 사례 출판 날짜
    2015-06-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135520
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    Software anomaly regarding urine samples that require acidified pretreatment. the software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.
  • 조치
    Ortho Clinical Diagnostics distributed correction notification letters dated April 6, 2015, and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1- 800-421-3311 anytime.

Device

VITROS 5,1 FS Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 6801375, 6801890 Unique Device Identifier Numbers: 10758750001132, 10758750001644
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide, Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
  • 제품 설명
    VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below || Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.
  • 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