Events

Device Recall VITROS 4600 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
    68790
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2140-2014
  • 사례 시작날짜
    2014-07-07
  • 사례 출판 날짜
    2014-08-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128684
  • 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
    Ortho clinical diagnostics has identified an anomaly with vitros system software version 3.0 and below. internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (id) number.
  • 조치
    On 7/07/2014, Customer Letter (Ref. CL2014-191) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them of the required actions. On 7/07/2014, Distributor Letter (Ref. DL2014-191 was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees instructing them to notify their consignees of the issue and required actions. Foreign affiliates were informed by e-mail on 7/07/2014 of the issue and instructed them to notify their consignees of the issue and required actions. For questions, please contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall VITROS 4600 Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers J46000108 - J46000440 (J Numbers are analogous to Serial Numbers, for VITROS 4600 systems the J Numbers start with 4600XXXX)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) 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 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).
  • 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