Events

BD MAX (tm) (6 channel) Instruments 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
    63949
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0701-2013
  • 사례 시작날짜
    2012-09-18
  • 사례 출판 날짜
    2013-01-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115099
  • 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
    Nucleic acid amplification assay system, group b streptococcus, direct specimen test - Product Code NJR
  • 원인
    Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
  • 조치
    Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4054.

Device

BD MAX (tm) (6 channel) Instruments
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  MX0001 to MX0065  CM0001 to CM0105  NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.
  • 제품 설명
    Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • 제조사 주소
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA