Events

Contour, Contour TS Blood Glucose Test Strips and Bonus Packs 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bayer Healthcare, LLC 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
    59467
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3268-2011
  • 사례 시작날짜
    2011-08-12
  • 사례 출판 날짜
    2011-09-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102842
  • 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 dehydrogenase, glucose - Product Code LFR
  • 원인
    All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of contour, contour ts and contour" usb blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of us fda-cleared performance specifications and produce a low-bias reading during blood.
  • 조치
    Bayer sent an "URGENT DIABETES TEST STRIP RECALL" letter dated August 12, 2011, to its customers with the name of the test strips, sizes recalled, reason for the recall, potential injury, and instructions to discontinue use and return the test strips to Bayer. The recall letter also included a recall response form that was to be faxed back to Bayer at 1-800-876-2243. For questions call Customer Logistics at 1-800-348-2637.

Device

Contour, Contour TS Blood Glucose Test Strips and Bonus Packs
  • 모델명 / 제조번호(시리얼번호)
    9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A 9579, 1802, 6181, 7070A, 9725, 9507C, and 9578.   Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials) the following lot numbers:DW0AC3B32A, DW0AC3B32C, DW0BC3B31A, DW0BC3B31B, DW0BC3D05B, DW0CC3B31A, DW0CC3B31B, DW0GC3B31C, DW0GC3B31D, DW0GC3B31F, DW0HC3B32A, DW9MC3B32D, DW9MC3B32E, DW9MC3B33A, and DW9MC3B33B.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution and Puerto Rico
  • 제품 설명
    Contour, Contour TS Blood Glucose Test Strips and Bonus Packs || Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
  • Manufacturer
    Bayer Healthcare, LLC

Manufacturer

Bayer Healthcare, LLC
  • 제조사 주소
    Bayer Healthcare, LLC, 430 S Beiger Street, Mishawaka IN 46544-3207
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    USFDA