Events

Device Recall BD Biosciences Trucount(TM) tubes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton, Dickinson and Company, BD Biosciences 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
    74537
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2252-2016
  • 사례 시작날짜
    2016-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147864
  • 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
    One lot of bd trucount absolute counting tubes (ivd) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.
  • 조치
    Urgent Product Correction notifications letters were sent on June 24, 2016 to all affected customers. Letters identify the issue and product and provide illustrations of the Kit Box and pouch labels. Correction letters identified the issue and the product involved with photos of product labels. BD letters states that they want to reinforce the need to visually inspect the desiccant contained in each pouch . If the desiccant has turned from blue to lavender, discard the remaining tubes. The acknowledgement form should be completed and returned regardless if any inventory remains. If you require further assistance, please contact BD Customer Support at 855.236.2772 (prompt 3) in the Unites States. For customers outside the US, contact your local BD Biosciences representative or distributor

Device

Device Recall BD Biosciences Trucount(TM) tubes
  • 모델명 / 제조번호(시리얼번호)
    Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ and Foreign to : Canada, Belgium and Chile
  • 제품 설명
    BD Trucount Tubes: || Catalog number: 340334 || Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
  • Manufacturer
    Becton, Dickinson and Company, BD Biosciences

Manufacturer

Becton, Dickinson and Company, BD Biosciences
  • 제조사 주소
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA