Events

Device Recall PTS Panels LDL Cholesterol 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
    53759
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1132-2010
  • 사례 시작날짜
    2008-05-29
  • 사례 출판 날짜
    2010-03-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86474
  • 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, low density, lipoprotein - Product Code MRR
  • 원인
    The expiration date was extended by 20 weeks without justification.
  • 조치
    An "URGENT-FIELD CORRECTION" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records. If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.

Device

Device Recall PTS Panels LDL Cholesterol test strips
  • 모델명 / 제조번호(시리얼번호)
    Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution
  • 제품 설명
    PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. || For the quantitative measurement of LDL cholesterol 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