Events

Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA 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
    56775
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0489-2011
  • 사례 시작날짜
    2010-07-23
  • 사례 출판 날짜
    2010-11-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94516
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    The vent needle, which is built into the vent head assembly on the cell-dyn sapphire instrument and which is used directly on the cell-dyn 4000 instrument, may be defective, which may result in an undetected short sample, generating incorrect low results, or which may bend, preventing aspiration of the sample.
  • 조치
    Abbott Laboratories issued a Product Recall letter dated July 23, 2010 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were instructed to discard all affected vent needles and replace them with the needle included with the recall letter. Customers may contact customer support at 1-877-422-2688 concerning this recall.

Device

Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly
  • 모델명 / 제조번호(시리얼번호)
    Manufacturing date codes between 01.Jan.2010 and 23.Jun.2010
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.
  • 제품 설명
    CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; || CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, || CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, || CELL-DYN 4000 Vent Needle, List Number: 02H61-01, || CELL-DYN 4000 Accessory Kit, List Number: 01H20-01, || CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576, || CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101, || CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201; || Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
  • Manufacturer
    Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

Manufacturer

Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
  • 제조사 주소
    Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA