Device Recall BD FACS 7color Setup Beads 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 BD Biosciences, Systems & Reagents 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
    62494
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2397-2012
  • 사례 시작날짜
    2012-06-29
  • 사례 출판 날짜
    2012-09-17
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-03-25
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    Incorrect version of the cd was included with bd facs 7 color setup beads.
  • 조치
    BD Biosciences sent a Important Product Recall Information letter beginning July 3, 2012, to all affected consignees via Fed Express. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed that the CD enclosed in their recent purchase of BD FACS 7-Color Setup Beads, lot number 33412, contain CD version 2.0 instead of the newer version 3.0. The letter goes on to explain the the potential risk and include a table of listed range values to determine if a potential false pass or false fail for the listed detectors has occurred. Customers are asked to check the CD with the kit to ensure that it is version 3.0 (the kit lot number ID is on the CD label). If it is not the correct version, discard version 2.0 and do not use it with this bead kit. Call BAD customers service for a replacement. If the 2.0 kit was already uses, letters request that clinicians inspect the FITC and APC-CY7 stains in the plots of the laboratory reports for the clinical applications in BD FACSCanto clinical software for compromised resolution between negative and dim populations. The verification form/effectiveness check should be completed and returned as requested. Questions or concerns may be directed to BD Customer Support at 1-855-236-2772.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 335775; Lot number 33412.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
  • 제품 설명
    BD FACS 7-color Setup beads || BD Biosciences, San Jose, CA 95131. || BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
  • Manufacturer

Manufacturer

  • 제조사 주소
    BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
  • 제조사 모회사 (2017)
  • Source
    USFDA