Events

ARCHITECT LACTIC ACID 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
    75448
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0379-2017
  • 사례 시작날짜
    2016-10-11
  • 사례 출판 날짜
    2016-11-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150391
  • 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
    Acid, lactic, enzymatic method - Product Code KHP
  • 원인
    Abbott has identified negative interference from the drug n-acetyl cysteine (nac) with the architect lactic acid reagent (ln 9d89-21).
  • 조치
    Abbott Laboratories sent an Product Correction Immediate Action Required letter dated October 10, 2016, to all affected customers. Please review this letter with your Medical Director Taking the above information into consideration, you may continue to use ARCHITECT Lactic Acid reagent (LN 9D89-21) Please complete and return the Customer Reply Form If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter Please retain this letter for your laboratory records. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service. For further questions please call (847) 937-2550.

Device

ARCHITECT LACTIC ACID
  • 모델명 / 제조번호(시리얼번호)
    Lot: 31497UN14 Exp.: 17 Oct. 2016; Lot: 09353UNI15 Exp.: 12 Feb. 2017; Lot: 45216UN15 12 May 2017; Lot: 14596UN15 Exp.: 30 Jul. 2017; Lot: 37055UN15 Exp.: 12 Oct. 2017; Lot: 14782UN16 Exp.: 21 Apr. 2018
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and Worldwide Distribution.
  • 제품 설명
    ARCHITECT Lactic Acid Part # 09D891T21 || The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
  • 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