Device Recall Cobas 8100 bidirectional reformatter (BRF) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Diagnostics Corporation 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
    76628
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1763-2017
  • 사례 시작날짜
    2017-03-01
  • 사례 출판 날짜
    2017-03-23
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-07-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • 원인
    "roche diagnostics corp. initiated a voluntary correction because a rack crash may occur on the cobas 8100 bi-directional reformatter (brf) and uni-directional reformatter (urf) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. this issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.".
  • 조치
    Roche initiated a recall on 03/01/2017, notices were issued via UPS to customers and instructed customers to do the following: Roche is developing software version 03-01 to resolve this issue, and a Roche Representative will be contacting you in the near future to schedule an update. Until this software update is available, the rack buffering option for the BRF and URF modules must be disabled. If you are an authorized cobas 8100 automated workflow series operator, follow the steps outlined below to disable rack buffering. If your facility does not have an authorized cobas 8100 automated workflow series operator, please contact the Roche Support Network Customer Support Center at 1-800-428-2336 for further steps. If you have a major spill, set the affected module to offline and contact the Roche Support Network Customer Support Center at 1-800-428-2336. " If you are an authorized cobas¿ 8100 automated workflow series operator, follow the steps outlined in this Urgent Medical Device Correction (UMDC) to disable rack buffering. " If your facility does not have an authorized cobas 8100 automated workflow series operator, please contact the Roche Support Network Customer Support Center at 1-800-428-2336 for further steps. " Complete the attached faxback form and fax it to 1-888-345-0024. " File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx  Catalog Number: 743995400
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
  • 제품 설명
    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
  • Manufacturer

Manufacturer

  • 제조사 주소
    Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
  • Source
    USFDA