Events

Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar 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
    73783
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1559-2016
  • 사례 시작날짜
    2016-03-28
  • 사례 출판 날짜
    2016-04-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144969
  • 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
    Culture media, selective and differential - Product Code JSI
  • 원인
    Trypticase tm soy agar with 5% sheep blood (tsa iitm) // macconkey ii agar is contaminated with listeria monocytogenes. the device is a non-sterile prepared plated media.
  • 조치
    BD sent an Urgent Product Recall letter dated March 2016 to all US customers via UPS or email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected lots and discard any remaining product. BD will replace the discard inventory. Customers were asked to complete and fax the attached form to : Attention Regulatory Compliance, Fax: 410-316-4258 or email to BDRC2@bd.com.

Device

Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar
  • 모델명 / 제조번호(시리얼번호)
    Cat. Number Lot Number 221291 6034889
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.
  • 제품 설명
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar || Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 || Product is sold in cartons of 100 plates each. || Product Usage: || Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • 제조사 주소
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA