Events

AxSYM Folate Reagent Pack 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 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
    37887
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1029-2007
  • 사례 시작날짜
    2007-04-23
  • 사례 출판 날짜
    2007-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-05-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52070
  • 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
    Reagent - Product Code CGN
  • 원인
    Failure of the axsym instrument to open (actuate) some reagent packs from certain lots. the defects can result in probe crashes if not detected prior to placement of the reagent kit on the axym instrument.
  • 조치
    Abbott initiated a field correction recall by letter dated 4/23/07 to all customers receiving the affected reagents. The accounts were informed of the failure of the AxSYM to open (actuate) some reagent packs with the affected lots. The accounts were requested to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading the reagent pack on the instrument; and discard any reagent packs that do not open properly. If the user observes a probe crash, prior to testing samples again, the user must perform a probe crash recovery following the procedure in the Operations Manual. If necessary, they need to replace the probe. If a probe crash recovery is not performed, subsequent results may be impacted. The customers were requested to retain a copy of the letter for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.

Device

AxSYM Folate Reagent Pack
  • 모델명 / 제조번호(시리얼번호)
    list 03C81; 49488M200, 50483M200
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.
  • 제품 설명
    AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 제조사 주소
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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