Events

PTS Panels(R) Glucose Test Strips 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Polymer Technology Systems, 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
    65067
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1403-2013
  • 사례 시작날짜
    2013-04-04
  • 사례 출판 날짜
    2013-05-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117830
  • 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
    System, test, blood glucose, over the counter - Product Code NBW
  • 원인
    Internal investigation demonstrated under-recovery for glucose when tested against a reference method. this could result in a low to moderate health risk.
  • 조치
    Polymer Technology Systems sent a Field Correction Action letters dated April 4, 2013 to distributors and customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use and dispose of remaining inventory of recalled product. Customers were asked to acknowledge and confirm recall directions were follwed by fax to 1-317-870-5608.

Device

PTS Panels(R) Glucose Test Strips
  • 모델명 / 제조번호(시리얼번호)
    U1117
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
  • 제품 설명
    PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers || Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
  • Manufacturer
    Polymer Technology Systems, Inc.

Manufacturer

Polymer Technology Systems, Inc.
  • 제조사 주소
    Polymer Technology Systems, Inc., 7736 Zionsville Rd, Indianapolis IN 46268-2175
  • 제조사 모회사 (2017)
    Sinocare Inc.
  • Source
    USFDA