Events

Device Recall MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47 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
    61610
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1499-2012
  • 사례 시작날짜
    2011-06-16
  • 사례 출판 날짜
    2012-05-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108538
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • 원인
    Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
  • 조치
    Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.

Device

Device Recall MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo T...
  • 모델명 / 제조번호(시리얼번호)
    lot code 2011-12-15.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Turkey, Poland, and Great Britain.
  • 제품 설명
    MicroScan Dried Overnight Gram Negative Panels; || Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417. || Siemens Healthcare Diagnostics, || West Sacramento, CA. || For use in determining quantitative and / or qualitative antimicrobial agent susceptibility and / or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA