Events

Device Recall VITROS Chemistry Products Vapor Adsorption Cartridge 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
    63934
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0755-2013
  • 사례 시작날짜
    2012-12-13
  • 사례 출판 날짜
    2013-01-30
  • 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=115070
  • 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
    Some vitros¿ chemistry products vapor adsorption cartridge cat no. 6800100 cartons incorrectly contain a particulate cartridge part no. j19612. in some instances, the particulate cartridge has been inadvertently installed on the vitros¿ system instead of the intended vitros¿ vapor adsorption cartridge which may bias results.
  • 조치
    Ortho-Clinical Diagnostics sent URGENT PRODUCT CORRECTION Letters (dated 12/13/12) along with Q&A; and Confirmation of Receipt Forms to distributors and consignees on 12/13/12. They were advised of the issue and instructed to discard their current inventory of VITROS¿ Vapor Adsorption Cartridges. On 12/13/12, foreign affiliates were informed by e-mail of the issue and instructed to notify their consignees of the issue and actions.

Device

Device Recall VITROS Chemistry Products Vapor Adsorption Cartridge
  • 모델명 / 제조번호(시리얼번호)
    CAT No. 680 0100; the cartridges do not have lot numbers.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.
  • 제품 설명
    Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600, VITROS¿ 5600, and VITROS¿ ECi/ECiQ 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