Events

enGen Laboratory Automation Systems 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
    68270
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1738-2014
  • 사례 시작날짜
    2014-04-10
  • 사례 출판 날짜
    2014-06-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127244
  • 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 (photomertic, discrete), for clinical use - Product Code JJE
  • 원인
    Software anomaly: potential for delay in the reporting of patient sample test results when using engen with tcautomation software v2.6 , v3.2 and v3.5 configured with bypass modules for advia centaur, abbott architect, vitros and/or tosoh aia systems.
  • 조치
    Urgent Product Correction Letters (CL2014-114, dated 4/10/2014) were sent to all US customers and Foreign affiliates starting on 4/10/2014. The letter informed customers of the issue and provided required actions to be taken: Routinely monitor your Bypass module(s) -- If you detect a stoppage due to the software timing issue, follow the steps in the How to Detect the Bypass Module Time Issue and Release the Samples section on Page 2 of this notification. -- Complete the Confirmation of Receipt Form and return by 4/23/2014. -- Place this notification near each system or with your enGen (TM) Laboratory Automation System user documentation.

Device

enGen Laboratory Automation Systems
  • 모델명 / 제조번호(시리얼번호)
    TCA Software versions 2.6 , 3.2 and 3.5 configured with Bypass Modules for ADVIA Centaur (R), Abbott Architect (TM), VITROS (R) and/or Tosoh AIA (R) Systems
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US Nationwide including Puerto Rico, and countries of: Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
  • 제품 설명
    enGen Laboratory Automation Systems (enGen) || with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: 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. In addition to an Automated Track Sub-system, the enGen System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass. If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing.
  • 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