Events

Device Recall PTS Panels Creatinine 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
    61966
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1903-2012
  • 사례 시작날짜
    2012-05-15
  • 사례 출판 날짜
    2012-06-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109606
  • 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
    Enzymatic method, creatinine - Product Code JFY
  • 원인
    During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 cardiocek pa meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the cardiochek pa meter for the creatinine assay.
  • 조치
    Polymer Technology Systems, Inc sent a URGENT FIELD CORRECTION letter dated May 15, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers to discontinue use and dispose of the product. PTS Inc. will provide appropriate replacement for any product that is properly identified on the attached Customer Acknowledgement and confirmation letter, If you have any questions please contact Customer Service toll-free at 1-877-870-5610, or +1-317-870-5610 ( outside the US )

Device

Device Recall PTS Panels Creatinine test strips.
  • 모델명 / 제조번호(시리얼번호)
    Cat No. 1720; and Lot number F103
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
  • 제품 설명
    PTS Panels Creatinine test strips. || PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
  • 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