Events

Clinical Chemistry Iron/Magnesium Calibrator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 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
    48172
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0950-2009
  • 사례 시작날짜
    2008-04-24
  • 사례 출판 날짜
    2009-02-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-07-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70929
  • 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 Mixture Calibrator - Product Code JIX
  • 원인
    An incorrect magnesium calibrator 2 value (cal 2) was provided for clinical chemistry iron/magnesium calibrator lot number 54187m200. use of the incorrect magnesium cal 2 value causes quality control and patient magnesium results to be reduced by as much as 17.24% above 0.8meq/l (1.0 mg/dl or 0.4 mmol/l).
  • 조치
    On April 24, 2008, a Product Correction letter with attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. Customer reply form were included in all US customers letter. The letter instructed customers to: 1. Identify the lot number of Clinical Chemistry Iron/Magnesium Calibrator currently used in your laboratory 2. If you have lot number 54187M200, cross out the incorrect Magnesium CAL 2 value in the value sheet, commodity 30-3535/R1, June 2005. Place a copy of this letter in all calibrator kits with this lot number. 3. Enter the revised Magnesium CAL 2 value provided in this letter in your system. NOTE: Ensure that the value used corresponds to the units of concentration used in your laboratory. *ARCHITECT cSystems - Refer to Enter a calibrator concentration (cSystem) in Section 2, Installation procedures and special requirements of the ARCHITECT System Operations Manual. *AEROSET - Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual. 4. Calibrate the Magnesium assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory. Customers were also instructed to please retain this communication for future reference and if they have forwarded any Clinical Chemistry Iron/Magnesium Calibrator to another laboratory, please provide a copy of this letter to them. An 800 number was provided in the recall letter for any questions the affected customers or any of the health care providers they serve may have.

Device

Clinical Chemistry Iron/Magnesium Calibrator
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 54187M200
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI, and countries of Mexico, Chile, Puerto Rico, Canada, Thailand, Curacao, Guatemala, Argentina, Dominican Republic, Germany, New Zealand, Jamaica, Ecuador, Brazil, El Salvador, Hong Kong, and Bermuda.
  • 제품 설명
    Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: 54187M200 || For use in the calibration of the Iron and Magnesium assays.
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

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