Events

Device Recall ADVIA Chemistry XPT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, Inc. 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
    74830
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2704-2016
  • 사례 시작날짜
    2016-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148550
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • 원인
    Siemens identified an issue with the ratio equation provided on the advia chemistry xpt system software test definition (tdef) version 1.0 disks (smn: 11127343 and 11222123). this issue affects only the advia chemistry hemoglobin a1c_3 automated pretreatment (a1c_3) results when hba1c values are reported in international federation of clinical chemistry (ifcc) equivalent units (hba1cr). the ratio equation used to calculate advia chemistry hemoglobin a1c_3 automated pretreatment (a1c_3) results in ifcc units contains an error. the error results in falsely depressed hba1cr results.
  • 조치
    Siemens sent an Urgent Field Safety Notice dated July 20, 2016, to all affected customers via Fed Ex and the Urgent Field Safety Notice (CHSW16-02 July 2016) was e-mailed to regional countries for implementation Outside US (OUS). Customers have been advised to stop reporting results and call Siemens immediately to schedule service. The file with the typographical error is located on ADVIA Chemistry XPT Test Definition (TDef) disk. -- Field service personnel were sent a support bulletin describing the issue and instructing them how to correct the equation. Service engineers have been instructed to remove all version 1.0 TDef disks from customer sites regardless of whether they run the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment assay and report in IFCC units. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative.

Device

Device Recall ADVIA Chemistry XPT
  • 모델명 / 제조번호(시리얼번호)
    CA1275002940294 and lower
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to MA, NY, MI, IL, TX, CO, AZ, CA, WA and Foreign distribution to the following countries: Australia, Austria, Bahrain, Brazil, China, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Malaysia, Netherlands, New Zealand, Norway, Portugal, Portugal, Republic Korea, Singapore, Slovakia, Spain, Sweden, Turkey, United Kingdom, and Vietnam.
  • 제품 설명
    ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). || The ADVIA Chemistry XPT System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA