Events

Device Recall FilmArray Blood Culture Identification Panel 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 BioFire Diagnostics, LLC 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
    79514
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1513-2018
  • 사례 시작날짜
    2018-03-14
  • 사례 출판 날짜
    2018-04-25
  • 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=162542
  • 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
    Gram-Negative bacteria and associated resistance markers - Product Code PEN
  • 원인
    There is an increased risk of false positive proteus results when the product is used with specific types of bd bactec blood culture bottles.
  • 조치
    The recalling firm initiated the recall on several different dates and methods: Via email on 3/14/2018 with the letter dated 3/3/2018 attached, via USPS on 3/23/2018, and via FedEx between 3/24/2018 and 3/28/2018. The recalling firm conducted an expansion and issued letters dated 6/11/2018 via FedEx or USPS on 6/13/2018.

Device

Device Recall FilmArray Blood Culture Identification Panel
  • 모델명 / 제조번호(시리얼번호)
    All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127).  The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.
  • 제품 설명
    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
  • Manufacturer
    BioFire Diagnostics, LLC

Manufacturer

BioFire Diagnostics, LLC
  • 제조사 주소
    BioFire Diagnostics, LLC, 515 S Colorow Dr, Salt Lake City UT 84108-1248
  • 제조사 모회사 (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA