Events

Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.'' 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Provalis Diagnostics 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
    32571
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0171-06
  • 사례 시작날짜
    2005-05-20
  • 사례 출판 날짜
    2005-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40371
  • 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
    Assay, Glycosylated Hemoglobin - Product Code LCP
  • 원인
    Provalis diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it hba1c test cartridges.
  • 조치
    All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff.

Device

Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartri...
  • 모델명 / 제조번호(시리얼번호)
    Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA.
  • 제품 설명
    Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.''
  • Manufacturer
    Provalis Diagnostics

Manufacturer

Provalis Diagnostics
  • 제조사 주소
    Provalis Diagnostics, 7380 W Sand Lake Rd Ste 500, Orlando FL 32819-5257
  • Source
    USFDA