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
    64577
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1107-2013
  • 사례 시작날짜
    2013-02-07
  • 사례 출판 날짜
    2013-04-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116521
  • 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, inc. (ocd) determined that extension springs on some vitros¿ systems may be out of its manufacturing specifications. extension springs are part of the slide alignment guide assembly. during an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. if the extension spring does not provide sufficient force, microslides may not be properly positioned within the microslide incubator which has the potential to cause imprecise results. extension springs are just one component in the slide alignment assembly. ocd's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
  • 조치
    URGENT MEDICAL DEVICE CORRECTION letters were sent to the consignees on 2/07/13. On/about 2/07/13, OCD trained service personnel started to perform an assessment of all the VITROS¿ System(s) in End-User facilities worldwide to determine if the extension springs are out of manufacturing specifications. In addition, the slide alignment guides will also be inspected. If the extension springs are out of specification they will be replaced. Consignees will also be provided with a communication that explains the issue.

Device

Device Recall VITROS 4600 Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers 46000108 through 46000217
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.
  • 제품 설명
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. || Intended for use in the measurement of a variety of chemistry analytes.
  • 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