Events

Lifescan OneTouch SureStep Meter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lifescan 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
    33121
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0101-06
  • 사례 시작날짜
    2005-09-09
  • 사례 출판 날짜
    2005-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41344
  • 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
    Glucose Oxidase, Glucose - Product Code CGA
  • 원인
    The lcd of the onetouch surestep meter may display incorrectly, resulting in missing segments on the display. this display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.
  • 조치
    On 9/9/05, ***and 4/14/06 (expanded)***the firm notified its consumers, Health Care Professionals (HCPs), pharmacies, and direct accounts (including wholesalers and distributors) by letter and phone calls.

Device

Lifescan OneTouch SureStep Meter
  • 모델명 / 제조번호(시리얼번호)
    The following are numbers (kit configurations) are affected by this recall: 010-341-18(OT SureStep system), 010-341-20 (OT SureStep System), 010-341-52 (OT SureStep starter kit), 010-411-06 (OT SureStepE Meter Warranty), 091-041-106 (OT SureStep Meter Warranty PBK).  The following lot numbers are affected: 42711002-01, 42711002-02, 42711002-03, 42731001-01, 42731001-02, 42891003-01, 42901001-01, 42901001-02, 42901001-03, 42911002-01, 42911002-02, 42911002-03, 42921002-01, 42921002-02, 42931001-01, 42931001-02, 42931001-03, 42941001-01, 42941001-02, 42941002-01, 42941002-02, 42941002-03, 42951001-01, 42951001-02, 42951001-03, 42951002-01, 42951002-02, 42951003-01, 42951003-02, 42961001-02, 42961004-01, 42971002-01, 42971002-02, 42971002-03, 42971002-04, 42971002-05, 42971004-01, 42981001-01, 42981001-02, 42981001-03, 42981001-04, 42981001-05, 42981001-06, 42991001-01, 42991001-02, 42991001-03, 43621003-01, 43631001-01, 50051004-01, 50051004-02, 50051004-03, 50061001-01, 50061001-02, 50061001-03, 50081002-01, 50081002-02, 50081002-03, 50091001-01, 50091002-02, 50101001-01, 50101001-02, 50111001-01, 50111002-01, 50121001-01, 50121001-02, 50131001-01, 50131001-02, 50141001-02, 50141001-03, 50171001-04, 50311003-03, 50311003-04, 50321002-01, 50331001-02, 50351002-01, 50351002-02, 50361005-01, 50371001-01, 50371001-02, 50471001-04, 50481001-03.  ***On 4/14/06 the recall was expanded to include meters with Serial Numbers Between L3152Rxxxxxx and L5348Rxxxxxx, 31532002-01 to 53411001-01, 888-845-8904***
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Total amount of product distributed in the U.S. is 19,177 units, to distribution centers to be distributed to retailers, Health Care Professionals, wholesalers, and mail order companies. The product was distributed throughout the United States; 29,377 were distributed to Asia, Europe and Latin America.
  • 제품 설명
    Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • 제조사 주소
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6301
  • Source
    USFDA