Events

BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport SystemPink Cap 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
    54152
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0969-2010
  • 사례 시작날짜
    2009-09-18
  • 사례 출판 날짜
    2010-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-03-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87682
  • 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
    DNA-reagents, neisseria - Product Code MKZ
  • 원인
    Product was shipped beyond its expiration date.
  • 조치
    The recalling firm notified end users by letter flagged as "Urgent Product Recall" on 09/18/09. The notification advised that the referenced lot number had been correctly labeled with expiration date but had been shipped after the labeled date. End users were instructed to discontinue use discard product for replacement and return enclosed response form. If further assistance is needed regarding replacements, please contact SD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact SD Technical Services Department at 1-800-638-8663.

Device

BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport SystemPink Cap
  • 모델명 / 제조번호(시리얼번호)
    Lot 7016132, Exp date 01/17/09.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in Australia.
  • 제품 설명
    BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.