Events

Device Recall Cliniqa Liquid QCTM Cardiac Marker Control 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
    63309
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0192-2013
  • 사례 시작날짜
    2012-07-19
  • 사례 출판 날짜
    2012-11-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113476
  • 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
    Enzyme controls (assayed and unassayed) - Product Code JJT
  • 원인
    Abbott point of care (apoc) has determined that for the cliniqa liquid qc cardiac marker control for i-stat level 1 (list #06f12-09; lot number 071039); i-stat level 2 (list #06f12-10; lot number 081039); and i-stat level 3 (list #06f12-11; lot number 091039) results may be generated below the lower value assignment range for some vials.
  • 조치
    The firm, Abbott Point of Care, Inc. (APOC), sent an "URGENT RECALL NOTICE" dated July 2012 via FED-EX on July 19, 2012. The recall notice identified the product, problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of the control lot numbers; return all unused controls on the enclosed Customer Reply Form; If another institution was provided the controls, provide a copy of this notice to them. Note: if any used vials gave acceptable product performance, a review of the cartridge performance and associated patient results is not necessary) Note: APOC is shipping replacement products to customers facilities to minimize any disruption this might cause. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.

Device

Device Recall Cliniqa Liquid QCTM Cardiac Marker Control
  • 모델명 / 제조번호(시리얼번호)
    Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039)  Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10; Lot Number 081039)  Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11; Lot Number 091039)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA and WI; and country of: Italy.
  • 제품 설명
    Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) || Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) || Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) || Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB 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