Device Recall API NIH (REF 10400) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 BioMerieux SA 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
    67820
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1477-2014
  • 사례 시작날짜
    2014-03-06
  • 사례 출판 날짜
    2014-04-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-03-14
  • 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
    Device, general purpose, microbiology, diagnostic - Product Code LIB
  • 원인
    Biomerieux identified a visual defect and activity issue on the zym b reagent (ref 70493) and fb reagent (ref 70562). the activity issue lead to a false negative result of some rapid id 32 strips and api biochemical tests using the zym b reagent or fb reagent.
  • 조치
    Letters were issued to customers on March 10, 2014. The letter contained instructions to be used if they still were using the product. The letter also included a report form which was to be returned.

Device

  • 모델명 / 제조번호(시리얼번호)
    Code - 1002786740, Exp. Date 6/3/2014, 1002809140, Exp. Date 6/18/2014, 1002814890, Exp. Date 9/9/2014, 1002814891, Exp. Date 9/9/2014, 1002826750, Exp. Date 6/3/2014, 1002869720, Exp. Date 6/18/2014, 1002869721, Exp. Date 12/13/2014, 1002485910, Exp. Date 6/3/2014, 1002485911, Exp. Date 6/18/2014
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • 제품 설명
    API NIH (REF 10400). || ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
  • Manufacturer

Manufacturer

  • 제조사 주소
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • 제조사 모회사 (2017)
  • Source
    USFDA