Events

ABBOTT Clinical Chemistry 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
    49597
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0580-2009
  • 사례 시작날짜
    2008-09-12
  • 사례 출판 날짜
    2009-01-12
  • 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=73893
  • 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 field action was initiated after an investigation for the total bilirubin reagents (list number 8g62 and list number 6l45) determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the diazo method. the matrix of this secondary standard caused a positive bias. because of these findings, a new total bilirubin calibrator value assignm.
  • 조치
    On September 12, 2008, a Product Correction letter with an attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. The letter instructed customers to take the following actions: 1. Identify the lot number(s) of Clinical Chemistry Bilirubin Calibrator currently used in your laboratory; 2. Replace the calibrator value sheet with the appropriate attachment provided with this letter. Discard the previous calibrator value sheet; 3. Configure the revised Total Bilirubin calibrator values provided in the Attachments, for the appropriate calibrator lot number and reagent list number. ARCHITECT cSystems: Refer to System Configuration in Section 2, Installation Procedures and Special Requirements in 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 Total Bilirubin assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory; 5. Evaluate your quality control. Shifts in quality control and proficiency testing samples may vary among laboratories and should be evaluated according to your laboratory procedures. NOTE: Refer to the Attachments (E and F) for the representative shift with the revised calibrator values (Patient sample and Control/QC recovery); and 6. Evaluate your reference range and any shifts in patient results. It is recommended that each laboratory established its own expected ranges, which may be unique to the population it serves. Please retain this communication for future reference. If you have forwarded any Clinical Chemistry Bilirubin Calibrator to another laboratory, please provide a copy of this letter to them. For questions, please contact ABBOTT Customer Service at 877-422-2688 (or 877-4ABBOTT). Customers outside of the

Device

ABBOTT Clinical Chemistry Calibrator
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 61388M100, 57919M100, 54754M100, and 52632M100.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including United States, Mexico, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina, Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador, Singapore, Australia, Curacao and Cayman Island.
  • 제품 설명
    ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. || The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples.
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

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