Events

Device Recall VITROS ECiQ Immunodiagnostic 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
    60847
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0924-2012
  • 사례 시작날짜
    2011-08-24
  • 사례 출판 날짜
    2012-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106637
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • 원인
    Software defect; ortho clinical diagnostics received complaints of observed results from diluted samples that were reported as <2.39 miu/ml (iu/l) instead of the correct no result, which is accompanied by an invalid dilution (id) code. the diluted results were inconsistent with results from the neat (undiluted) sample, which was within the measuring range of 2.39 - 15,000 miu/ml. ocd's investigation determined it is possible to obtain negatively biased results if samples are diluted and tested on the vitros¿ eci/eciq system using vitros¿ b-hcg ii reagent packs, lots 0484 and above.
  • 조치
    Ortho Clinical Diagnostics (OCD) sent an URGENT Product Correction Notification letter dated August 24, 2011 via FedEx overnight letter to all US consignees with VITROS ECi/ECiQ Systems. Foreign Affiliates were also notified of the problem on August 24, 2011. The letters provided information regarding the affected product, the problem, the actions to be followed prior to reporting results from their laboratory and a Question and Answer Section. Customers were instructed to 1) Post the enclosed Procedure for Reviewing VITROS Total B-hCG II Results near the VITROS ECi/ECiQ System to advise operators of this issue and assist them in reviewing results from diluted samples; 2) Users should consult with their Laboratory Medical Director and request a physician to resolve any concerns users may have regarding previously reported results from Lots 0484 and above of VITROS Total B-hCG II Reagent Packs; 3) Complete and return the attached Confirmation of Receipt form upon receipt of this notification; and 4) Forward the information in this notification if you have distributed this product outside of your facility. For additional questions contact OCD Customer Technical Services at 1-800-421-331.

Device

Device Recall VITROS ECiQ Immunodiagnostic System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers between 30003000 and 30005177; All VITROS¿ ECi/ECiQ systems that have Software Version 3.8 or below installed and on which the VITROS¿ B-hCG II (human chorionic gonadotropin) Reagent Packs is processed are affected by this correction. --- Note: All systems that are installed worldwide have Software Version 3.8 or lower installed on them, but B-hCG is not processed on all systems worldwide.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • 제품 설명
    VITROS¿ ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS¿ ECiQ System --- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS¿ Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. || Product Usage: || For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA