Device Recall BacT/ALERT SN 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 bioMerieux, 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
    73027
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0749-2016
  • 사례 시작날짜
    2015-12-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-12-04
  • 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
    System, blood culturing - Product Code MDB
  • 원인
    Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
  • 조치
    Biomerieux sent a Product Recall Notice letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the referenced part and lot number and discard remaining inventory according to their facility's procedure for culture media. Customers were also instructed to contact their local bioM¿rieux representative for product replacement.

Device

  • 모델명 / 제조번호(시리얼번호)
    Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
  • 제품 설명
    BacT/ALERT¿ SN, bioM¿rieux, Inc. || Product Usage: || BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
  • Manufacturer

Manufacturer

  • 제조사 주소
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • 제조사 모회사 (2017)
  • Source
    USFDA