Events

iSTAT Level 2 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
    56392
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1020-2011
  • 사례 시작날짜
    2010-08-03
  • 사례 출판 날짜
    2011-02-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93425
  • 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
    Multi- analyte controls, all kinds (assayed) - Product Code JJY
  • 원인
    Three i-stat level 2 control value assignment sheets and the i-stat clew a20 software system manual update cd contain the incorrect range for pco2, bun and glucose for the i-stat ec8+, 6+, ec4+, e3 and g cartridge types.
  • 조치
    Abbott Point of Care Inc., sent an URGENT RECALL NOTICE to all affected customers on 8/3/2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to replace all copies of the value sheets with the ones provided in the letter. ASLO, if they have a disc with the Value sheets on it, it is to be replaced with the updated disc and the original discarded. If the control materials, discs or value sheets have been forwarded to another facility, a copy of the letter was to be sent to them. The Business Reply card is to be completed and returned to Abbott. Questions or comments are to be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1.

Device

iSTAT Level 2 Control
  • 모델명 / 제조번호(시리얼번호)
    Abbott List Number: 06F13-01; Lot number B09342 - CLEW A20 artwork 726778-01A.pdf; Lot number B09154 - CLEW A20 artwork 726774-01A.pdf; Lot number B09342 - CLEW A18 artwork 726668-01A.pdf. Expiration: 11/2010. Abbott List Number: 025715, CLEW A20 Compact Disc containing value assignment sheets.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of Argentina, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, El Salvador, France, Georgia Republic, Germany, Hong Kong, Israel, Italy, Kuwait, Mexico, Netherlands, New Zealand, Panama, Paraquay, Peru, Poland, South Africa, Sweden, Switzerland, Taiwan, Turkey, UAE, UK, Uruquay, and Yemen.
  • 제품 설명
    i-STAT Level 2 Control Value Assignment Sheets || Human Consumption
  • 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