Events

Device Recall Cardiac Marker Control Level 1, Cardiac Marker Control Level 2, & Cardiac Marker Control Level 3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Point Of Care 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
    57742
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1863-2011
  • 사례 시작날짜
    2010-12-17
  • 사례 출판 날짜
    2011-04-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97297
  • 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
    Single (Specified) Analyte Controls (Assayed and Unassayed) - Product Code JJX
  • 원인
    Presence of co2 in the head space of the vial can result in the generation of high results in cardiac marker control level 1, 2, and 3 which is used along with the cardiac marker control calibration verification set.
  • 조치
    Urgent Recall Notice letters with business reply cards were sent Fed ex on December 17, 2010 to all accounts. International notifications were sent on December 21, 2010. The letter identified the affected product and lot numbers along with a background explanation of the issue. The firm recommends that customers remove the cap from the vial; squeeze the vial 10 times, prior to thawing; replace cap on the vial; and then follow the remaining steps for use as outlines in section 14-12 of the i-STAT 1 System Manual. Customers are to complete and return the Business Reply card to acknowledge receipt of the letter. If the affected product had been further distributed then a copy of the letter should be provided to those customers as well. If additional information is needed, customers should contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or their Abbott Point of Care representative.

Device

Device Recall Cardiac Marker Control Level 1, Cardiac Marker Control Level 2, & Cardiac Marker C...
  • 모델명 / 제조번호(시리얼번호)
    Cardiac Marker Control Level 1 - Lot number M102081; Cardiac Marker Control Level 2 - Lot number M102082; and  Cardiac Marker Control Level 3 - Lot number M102083.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02. || Used to verify the integrity of newly received i-STAT cTnI cartridges.
  • Manufacturer
    Abbott Point Of Care Inc.

Manufacturer

Abbott Point Of Care Inc.
  • 제조사 주소
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 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