Events

Roche OMNI S Analyzer: cobas b 2216Roche OMNI S6 system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Diagnostics Operations, 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
    75569
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0673-2017
  • 사례 시작날짜
    2016-10-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150817
  • 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
    Electrode, ion specific, urea nitrogen - Product Code CDS
  • 원인
    Incorrect urea results may be generated sporadically on cobas b 221<6>roche omni s6 system and cannot be detected by qc. qc measurement results can be affected as well. this issue is only detectable if comparison result of a second measurement is available. the cause for this issue is an error in the software measurement procedure. in children, decreased urea results can point at inborn disorders or urea cycle. therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. no severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. a medical risk cannot entirely be excluded.
  • 조치
    Roche sent an Urgent Medical Correction letter dated October 31, 2016, to all affected customers. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions Required " Use the workaround outlined in this Urgent Medical Device Correction (UMDC) for Urea measurement until the updated software version is available. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " Complete the attached fax form and fax it to 1-877-766-7471. " File this UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC.

Device

Roche OMNI S Analyzer: cobas b 2216Roche OMNI S6 system
  • 모델명 / 제조번호(시리얼번호)
    Lot Number(s): All lots within shelf life. Expiration Date(s): All
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI
  • 제품 설명
    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the || Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system || The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA