Events

Device Recall ABBOTT Clinical Chemistry Multiconstituent Calibrator List number: lE6502 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories Diagnostic Div 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
    34435
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0516-06
  • 사례 시작날짜
    2005-12-23
  • 사례 출판 날짜
    2006-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43861
  • 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
    Calibrator, Multi-Analyte Mixture - Product Code JIX
  • 원인
    The two multiconstituent calibrator (mcc) lot numbers 19906m200 and 20879m100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired. the expiration date for lot number 26674m100 will be revised from 2006-07-31 to 2006-01-31.
  • 조치
    A Device Correction letter identifying the changes being made to the expiration dating for lot numbers 19906M200, 20879MI00 and 26674M1O0 along with a Customer Reply form will be distributed via FedEx to all AEROSET and ARCHITECT c8000 customers which utilize the Clincial Chemistry Multiconstituent Calibrator on December 27,2005. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check.

Device

Device Recall ABBOTT Clinical Chemistry Multiconstituent Calibrator List number: lE6502
  • 모델명 / 제조번호(시리얼번호)
    Lot number(s): 19906M200 (expiration date 02/28/2006), 20879MIOO (expiration date 02/28/2006), & 26674MIOO (expiration date 07/31/2006)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide plus worldwide in Mexico,Venezuela, Chile, Brazil, San Salvador, Singapore, Korea, Trinidad, Grand Cayman, Guatemala, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, Australia, Bermuda, Jamaica, Costa Rica, Ecuador, Argentina, Dominican ReD., Germanv, Thailand, New Zealand, Bahamas, Panama, & Paraguay.
  • 제품 설명
    Clinical Chemistry Multiconstituent Calibrator--- || List number: lE65-02
  • Manufacturer
    Abbott Laboratories Diagnostic Div

Manufacturer

Abbott Laboratories Diagnostic Div
  • 제조사 주소
    Abbott Laboratories Diagnostic Div, 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA