Events

Device Recall BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA 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
    53961
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1009-2010
  • 사례 시작날짜
    2009-11-11
  • 사례 출판 날짜
    2010-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-05-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86954
  • 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
    system, blood culturing - Product Code MDB
  • 원인
    The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.
  • 조치
    An "URGENT CUSTOMER NOTIFICATION" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when used as instructions indicate. The customers are being urged to pay close attention to their BACTEC blood collection procedure until they receive bottles with the revised labels. Drawing too much blood may contribute to false negative or false positive results. The customer is being ask to communicate this information to all specimen collection sites within their facility. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
  • 모델명 / 제조번호(시리얼번호)
    9233292 exp 6/30/2010  9233294 exp 6/30/2010  9257192 exp 6/30/2010  9257221 exp 6/30/2010  9257224 exp 6/30/2010  9267233 exp 7/31/2010  9267236 exp 7/31/2010  9267238 exp 7/31/2010  9267240 exp 7/31/2010  9267242 exp 7/31/2010  9267243 exp 7/31/2010  9267244 exp 7/31/2010  9267245 exp 7/31/2010 9267246 exp 7/31/2010 9267249 exp 7/31/2010
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay
  • 제품 설명
    BD BACTEC(TM) Lytic 10 Anaerobic/F Medium, catalog 442265, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** || BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.