Events

Device Recall enGen Laboratory Automation 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
    71174
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1724-2015
  • 사례 시작날짜
    2015-05-06
  • 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=136349
  • 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
    Recapper caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. the gripper may grab a tube at the wrong height and drop the tube in the rack entry/exit or rack exit module. these situations may result in splashing of bio-hazardous fluid. sample cross-contamination may occur with an uncapped tube in the rack.
  • 조치
    On 5/06/2015, a customer letter (Ref. CL2015-092) with recommendation to prevent this issue was sent to all customers in the US with enGen Systems via FedEx or US Priority Mail (for Post Office Box addresses) or by email to subscribers of ORTHO PLUS e-Communications. Foreign affiliate consignees were notified by e-mail on 5/06/2015 informing them of the issue. For questions, please call Customer Technical Services at 1-800-421-3311 at any time.

Device

Device Recall enGen Laboratory Automation System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: J89134, JIM341226, 341516, JIM342964, JIM340432, JIM340814, IM341243, JIM336912, J271265, J271369, J271372, J271267, J85208, JIM342217, J7023890, J7023841, J7025007, J7024894, J7023648,  J7021530, J57662, J8006290, J75685, J30370, J3055510, J3055507, JIM341820, JIM341679, JIM341174, JIM340667, JIM-341592, JIM336957,  JIM341477, JIM336855, JIM334236, JIM341415, JIM341392, JIM340934,  JIM336167, JIM342249, JIM341750, JIM341426, JIM334527, JIM341021, JIM340658.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US Nationwide, Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom.
  • 제품 설명
    enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). || COMMON NAME: enGen Track System. The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.
  • 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