Events

Cobas 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Molecular Systems, 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
    79375
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1195-2018
  • 사례 시작날짜
    2017-10-27
  • 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=162147
  • 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
    System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen - Product Code NQX
  • 원인
    The cobas mrsa/sa tests may have decreased performance compared to the analytical sensitivity for msra detection. a screening failure can lead to potential infection in the colonized patient being tested as well as the spread of msra to others. the united states is not impacted, as the cobas mrsa/sa nucleic acid test for use on the cobas liat system is not available in the us.
  • 조치
    The cobas MRSA/SA tests has the potential for decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others.

Device

Cobas
  • 모델명 / 제조번호(시리얼번호)
    Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
  • 제품 설명
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA