Events

Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vital Diagnostics, Inc. 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
    55535
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1816-2010
  • 사례 시작날짜
    2010-04-12
  • 사례 출판 날짜
    2010-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91076
  • 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
    Tube, sedimentation rate - Product Code GHC
  • 원인
    The tube may fall out or separate from the slider adapter.
  • 조치
    Vital Diagnostics issued recall letter dated April 14, 2010 via Certified Mail in an envelop marked "Urgent Recall Information Inside", requesting accounts to discontinue use and destroy recalled product. A Certificate of Destruction and Refund Form was included to direct customers. A second Distributor Notice was sent by email to the distributors with Important Recall Information in the title. This was accompanied with the same Technical Bulletin, Certificate of Destruction and Refund Form. For further information, contact Vital Diagnostics at 1-800-345-2822.

Device

Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes
  • 모델명 / 제조번호(시리얼번호)
    All Lot Numbers
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide and Canada.
  • 제품 설명
    Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. || Slider allows a larger label to be applied to the ESR tube.
  • Manufacturer
    Vital Diagnostics, Inc.

Manufacturer

Vital Diagnostics, Inc.
  • 제조사 주소
    Vital Diagnostics, Inc., 27 Wellington Rd, Lincoln RI 02865-4411
  • 제조사 모회사 (2017)
    Ergon Capital Partners
  • Source
    USFDA