Events

Device Recall Elecsys BRAHMS PCT 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
    79462
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1311-2018
  • 사례 시작날짜
    2017-12-22
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162386
  • 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
    Device to detect and measure procalcitonin (PCT) in human clinical specimens - Product Code PMT
  • 원인
    Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the modular analytics e 170, cobas e 411, 601, and 602 analyzers.
  • 조치
    The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 22, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Immediately discontinue use of Elecsys BRAHMS PCT (catalog number 07301715190) reagent lot number 204084 on the cobas e 801 module. " Discard affected product according to local guidelines. " Complete the attached fax form and fax it to 1-800-722-7222. " File this Urgent Medical Device Removal (UMDR) 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 UMDR.

Device

Device Recall Elecsys BRAHMS PCT
  • 모델명 / 제조번호(시리얼번호)
    Elecsys BRAHMS PCT: 07301715190 Lot number 204084
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution in states of: CA, FL and IN.
  • 제품 설명
    Elecsys BRAHMS PCT || Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
  • Manufacturer
    Roche Diagnostics Corporation

Manufacturer

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