Events

Device Recall BD MAX" UVE Specimen Collection Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Co. 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
    78808
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0393-2018
  • 사례 시작날짜
    2017-07-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160563
  • 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
    Vaginitis and bacterial vaginosis nucleic acid detection system - Product Code NSU
  • 원인
    Bd recently notified customers in july 2017 regarding an increased rate of unresolved (unr) and indeterminate (ind) results for the bd maxtm vaginal panel, experienced by some customers. a non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
  • 조치
    Customers were notified via UPS on 07/18/2017. The recall for BD MAX" Vaginal Panel and BD MAX" UVE Specimen Collection Kit was initiated on July 18, 2017 and expanded to include BD MAX" CT/GC/TV on August 11, 2017. The recall expansion letter to customers was dated 08/14/2017.

Device

Device Recall BD MAX" UVE Specimen Collection Kit
  • 모델명 / 제조번호(시리얼번호)
    UDI: 30382904433766. All Lot numbers: All when used with catalog 443712, 443824 and 442970.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US and OUS.
  • 제품 설명
    BD MAX" UVE Specimen Collection Kit. || Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.