Events

ABL7XX Calibration 1 Solution S1720 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Radiometer America 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
    49468
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0457-2009
  • 사례 시작날짜
    2008-09-05
  • 사례 출판 날짜
    2008-12-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73497
  • 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
    Ion Specific Calcium Electrode - Product Code JFP
  • 원인
    The firm found that for this particular lot that the barcode, used for entering the characteristics of cal1 solution into the analyzer, does not reflect the actual values of the solution. as a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.
  • 조치
    On, 9/2/2008 the firm sent out recall notification letters requesting their customers discard any Calibration 1 Solution (CAL1) S1720 (part number 944-024), lot WA-04, complete the attached return form and fax it to 800-736-0601. The firm will send out replacements for all affected product that the firm shows was shipped to their location. Further questions could be directed to Technical Support at 800-736-0600, option 2.

Device

ABL7XX Calibration 1 Solution S1720
  • 모델명 / 제조번호(시리얼번호)
    P/N S1720, 944-024; Lot: WA-04
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.
  • 제품 설명
    ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 || Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA