Events

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
    75167
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0300-2017
  • 사례 시작날짜
    2016-09-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149527
  • 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 confirmed that it is possible for the mis-association of sample identification and assay results due to an error with thermo fishers centrifuge module. it is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the cross check error on the engen laboratory automation system. assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.
  • 조치
    The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" Letter (Ref. CL2016-183, dated 9/7/2016) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all enGen customers with centrifuge modules to inform them of the issue and advise them to check samples associated with cross check errors as instructed in the operator manual, and perform the preventative maintenance and cleaning procedures for that centrifuge module as provided in the maintenance manual and user guide. The customers were also instructed to Complete and return the Confirmation of Receipt form by 16 September 2016 via Fax: 1.888.557.3759 or 1.585.453.4110 or email:RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. For questions regarding this notification, please call the Ortho Care Solutions Center any time at 1-800-421-3311. Foreign affiliates were informed by e-mail on 9/7/2016 of the issue and instructed to notify their consignees of the issue and appropriate actions to take.

Device

enGen Laboratory Automation System
  • 모델명 / 제조번호(시리얼번호)
    Software Versions 3.6.1 and below; Affected US Serial Numbers: 5GV6W2J,GBX395J, J2QKG25J, 2Z3YV1J, 3RHC23J, 4HX7S4J, 54FC01J, 5J4B45J, 736BM4J, 7KSC15J, J86PWC5J, 953209, 953221, 953266, 953270, B3ZHP2J, CXL941J, JFBX395J, FCM073J, FXCBG3J, JG7BFB5J, GWXQ52J, HJ5K84J, HPKG25J -- Affected Foreign Serial Numbers: DWXO52J, GWJZY4J, J16XQH4J, BGV6W2J, 17QP94J, 4SHPF4J, 1K5K84J, 37QP34J, H5PWC5J, J2V6LW4J, F6MXR3J, JT6LW4J, N0551107, F1150698, 46XQH4J, 2S5OP0J, CRKM82, J41BCY4J, J56T205J, BGV6W2J, 7YCF43J, 96XQHAJ, C1JNZ5J, C3JTP4J, D3JTP4J, 86T205J, 18BFB5J, 96PWC5J, 1LSSF5J, 4drj44j, 8W7WG3J, J953222, J953244, JCT20Q3J, HWJZY4J, 38769917923.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-(Nationwide) and foreign distribution to the following countries: Belgium, Bermuda, Canada, Chile, Denmark, France, Italy, Mexico, Norway, Portugal, Sweden, Taiwan and United Kingdom.
  • 제품 설명
    enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code || 952040-EG 6844097. || The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation 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).
  • 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