Events

Device Recall OneTouch Verio IQ Blood Glucose Monitoring System Kit; 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
    61272
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1359-2012
  • 사례 시작날짜
    2012-02-21
  • 사례 출판 날짜
    2012-04-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107697
  • 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
    An error was discovered in the onetouch iq meter software so that the meter turns itself off when a user attempts to view results in the "results log" when the log has 256 or a multiple of 256 items to display.
  • 조치
    Lifescan sent an Urgent Medical Device Voluntary Recall letter dated February 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1. Identify and sequester all lots of OneTouch¿ Verio"IQ Meters they have in inventory. UPC No. 353885007702 LifeScan Part No. 022267 NDC No. 53885026701 Note: Only OneTouch¿ Verio"IQ Meters are subject to this notice. Please continue to sell all other OneTouch¿ Brand products including OneTouch¿ Verio" Test Strips and all OneTouch¿ Ultra¿ Brand Meters, Test Strips and Ancillary Products. 2. Communicate this replacement program to their distribution centers and retail stores that have received OneTouch¿ Verio"IQ Meters. Request that they return only OneTouch¿ Verio"IQ Meters per their normal return procedures. 3. Once you received all of the OneTouch¿ Verio"IQ Meters to be returned, call Inmar Corp. at 336-631-7744 for a Returned Goods Authorization (RGA) number and product return instructions. When product has been returned, a credit memo for an amount equivalent to the invoiced price of the returned product. No deductions will be allowed. If you have any questions about this action, please contact your LifeScan Sales Representative or call the LifeScan Customer Experience Line at: 1-800-600-7226, Option 1. Customers were advised that they can continue use of their affected product until an updated meter is provided free of charge. For questions regarding this recall call 408-942-5937.

Device

Device Recall OneTouch Verio IQ Blood Glucose Monitoring System Kit;
  • 모델명 / 제조번호(시리얼번호)
    Model numbers: 022-267-01 - System Kit; 022-268-01 - Starter Kit; 022-275-01 - Warranty Kit. Lot Number Part Number T1111008X 022-267-01 T1111009X 022-275-01 T1111024X 022-267-01 T1111027X 022-267-01 T1111030X 022-267-01 T1111033X 022-267-01 T1111035X 022-267-01 T1111037X 022-267-01 T1111039X 022-267-01 T1111041X 022-267-01 T1111042X 022-267-01 T1111043X 022-267-01 T1111045X 022-267-01 T1111046X 022-267-01 T1111047X 022-267-01 T1111048X 022-267-01 T1111050X 022-267-01 T1111051X 022-267-01 T1111054X 022-267-01 T1111055X 022-267-01 T1111056X 022-267-01 T1111058X 022-267-01 T1111060X 022-267-01 T1111061X 022-267-01 T1111062X 022-267-01 T1111064X 022-267-01 T1111065X 022-267-01 T1111066X 022-267-01 T1111067X 022-267-01 T1111068X 022-267-01 T1111069X 022-267-01 T1111071X 022-267-01 T1111072X 022-275-01 T1111074X 022-268-01 T1111075X 022-275-01 T1111076X 022-268-01 T1111077X 022-268-01 T1111080X 022-268-01 T1111081X 022-268-01 T1111082X 022-268-01 T1111084X 022-268-01 T1111086X 022-268-01 T1111087X 022-268-01 T1111088X 022-268-01 T1111089X 022-268-01 T1111090X 022-268-01 T1111091X 022-268-01 T1111092X 022-268-01 T1111093X 022-268-01 T1111094X 022-267-01 T1111095X 022-268-01 T1111096X 022-267-01 T1111097X 022-267-01 T1111098X 022-267-01 T1111099X 022-267-01 T1111100X 022-267-01 T1111101X 022-267-01 T1111103X 022-267-01 T1111105X 022-267-01 T1111107X 022-267-01 T1111109X 022-267-01 T1111110X 022-267-01 T1111111X 022-268-01 T1111112X 022-267-01 T1111113X 022-268-01 T1111114X 022-268-01 T1111115X 022-268-01 T1111116X 022-268-01 T1111117X 022-268-01 T1111118X 022-268-01 T1111119X 022-268-01 T1112009X 022-267-01 T1112011X 022-267-01 T1112013X 022-267-01 T1112015X 022-267-01 T1112016X 022-267-01 T1112017X 022-267-01 T1112019X 022-267-01 T1112020X 022-267-01 T1112022X 022-267-01 T1112023X 022-267-01 T1112025X 022-267-01 T1112026X 022-267-01 T1112027X 022-267-01 T1112028X 022-267-01 T1112029X 022-267-01 T1112030X 022-267-01 T1112031X 022-267-01 T1112032X 022-267-01 T1112033X 022-267-01 T1112034X 022-267-01 T1112037X 022-267-01 T1112062X 022-267-01 T1112063X 022-267-01 T1112065X 022-267-01 T1112066X 022-267-01 T1112067X 022-267-01 T1112068X 022-267-01 T1112069X 022-267-01 T1112070X 022-267-01 T1112071X 022-267-01 T1112072X 022-267-01 T1112073X 022-267-01 T1112074X 022-267-01 T1112075X 022-267-01 T1112076X 022-267-01 T1112077X 022-267-01 T1112078X 022-267-01 T1112079X 022-267-01 T1112080X 022-267-01 T1112081X 022-267-01 T1112082X 022-267-01 T1112083X 022-267-01 T1112084X 022-267-01 T1112085X 022-267-01 T1112086X 022-267-01 T1112087X 022-267-01 T1112088X 022-267-01 T1112089X 022-267-01 T1112090X 022-267-01 T1112092X 022-267-01 T1112093X 022-267-01 T1112094X 022-267-01 T1112095X 022-267-01 T1112096X 022-267-01 T1112097X 022-267-01 T1112098X 022-267-01 T1112099X 022-267-01 T1112100X 022-267-01 T1112101X 022-267-01 T1112102X 022-267-01 T1112103X 022-267-01 T1112104X 022-267-01 T1112105X 022-267-01 T1112106X 022-267-01 T1112107X 022-267-01 T1112108X 022-267-01 T1112109X 022-267-01 T1112110X 022-267-01 T1112111X 022-268-01 T1112112X 022-268-01 T1112113X 022-268-01 T1112114X 022-268-01 T1112115X 022-268-01 T1112116X 022-268-01 T1112117X 022-268-01 T1112118X 022-268-01 T1112119X 022-268-01 T1112120X 022-268-01 T1112121X 022-268-01 T1112122X 022-268-01 T1112123X 022-268-01 T1112124X 022-268-01 T1112125X 022-268-01 T1112126X 022-268-01 T1112127X 022-268-01 T1112128X 022-268-01 T1112129X 022-268-01 T1112130X 022-268-01 T1112131X 022-268-01 T1112132X 022-268-01 T1112133X 022-268-01 T1112134X 022-268-01 T1112135X 022-268-01 T1112136X 022-268-01 T1112137X 022-268-01 T1112138X 022-268-01 T1112139X 022-268-01 T1112140X 022-268-01 T1112141X 022-268-01 T1112142X 022-268-01 T1112143X 022-268-01 T1112144X 022-268-01 T1112145X 022-268-01 T1112146X 022-268-01 T1112147X 022-268-01 T1112148X 022-268-01 T1112149X 022-268-01 T1112150X 022-268-01 T1112151X 022-268-01 T1112152X 022-268-01 T1112153X 022-268-01 T1112154X 022-268-01 T1112156X 022-268-01 T1112157X 022-268-01 T1112158X 022-268-01 LifeScan Confidential Lot Number Part Number T1112159X 022-268-01 T1112160X 022-268-01 T1112162X 022-268-01 T1112163X 022-268-01 T1112164X 022-268-01 T1112165X 022-268-01 T1112167X 022-268-01 T1112168X 022-268-01 T1112169X 022-268-01 T1112170X 022-268-01 T1112172X 022-268-01 T1112173X 022-268-01 T1112174X 022-268-01 T1112175X 022-268-01 T1112177X 022-268-01 T1112178X 022-268-01 T1112179X 022-268-01 T1112180X 022-268-01 T1112181X 022-268-01 T1112182X 022-268-01 T1112183X 022-268-01 T1112184X 022-268-01 T1201001X 022-268-01 T1201002X 022-268-01 T1201003X 022-268-01 T1201004X 022-268-01 T1201005X 022-268-01 T1201006X 022-268-01 T1201007X 022-268-01 T1201008X 022-268-01 T1201009X 022-268-01 T1201010X 022-268-01 T1201011X 022-268-01 T1201012X 022-268-01 T1201013X 022-268-01 T1201014X 022-268-01 T1201015X 022-268-01 T1201016X 022-268-01 T1201018X 022-268-01 T1201019X 022-268-01 T1201021X 022-268-01 T1201022X 022-268-01 T1201024X 022-268-01 T1201025X 022-268-01 T1201035X 022-268-01 T1201036X 022-268-01 T1201037X 022-268-01 T1201040X 022-268-01 T1201041X 022-268-01 T1201043X 022-268-01 T1201044X 022-268-01 T1201046X 022-268-01 T1201047X 022-268-01 T1201049X 022-267-01 T1201050X 022-268-01 T1201052X 022-275-01 T1201053X 022-267-01 T1201054X 022-267-01 T1201057X 022-267-01 T1201058X 022-267-01 T1201061X 022-267-01 T1201062X 022-267-01 T1201065X 022-267-01 T1201066X 022-267-01 T1201068X 022-267-01 T1201070X 022-267-01 T1201071X 022-275-01 T1201072X 022-267-01 T1201073X 022-267-01 T1201074X 022-267-01 T1201076X 022-267-01 T1201079X 022-267-01 T1201081X 022-267-01 T1201084X 022-267-01 T1201088X 022-267-01 T1201091X 022-267-01 T1201095X 022-267-01 T1201099X 022-267-01 T1201102X 022-267-01 T1201111X 022-268-01 T1201113X 022-268-01 T1201114X 022-268-01 T1201115X 022-268-01 T1201116X 022-275-01 T1201117X 022-275-01 T1201118X 022-267-01 T1201119X 022-267-01 T1201120X 022-267-01 T1201124X 022-267-01 T1201125X 022-268-01 T1201126X 022-268-01 T1201127X 022-268-01 T1201128X 022-268-01 T1201129X 022-268-01 T1201130X 022-268-01 T1201131X 022-268-01 T1201132X 022-268-01 T1201133X 022-268-01 T1202001X 022-268-01 T1202002X 022-268-01 T1202003X 022-268-01 T1202004X 022-268-01 T1202005X 022-268-01 T1202006X 022-268-01 T1202007X 022-268-01 T1202008X 022-268-01 T1202009X 022-268-01 T1202010X 022-268-01 T1202011X 022-267-01 T1202012X 022-268-01 T1202013X 022-268-01 T1202014X 022-268-01 T1202015X 022-268-01 T1202016X 022-268-01 T1202017X 022-268-01 T1202018X 022-268-01 T1202019X 022-268-01 T1202020X 022-268-01 T1202021X 022-268-01 T1202022X 022-268-01 T1202023X 022-268-01 T1202027X 022-268-01 T1202029X 022-268-01 T1202030X 022-268-01 T1202031X 022-268-01 T1202035X 022-268-01 T1202038X 022-268-01. Expiration dates: 12/31/2012, 01/31/2013, 05/31/2013, 06/30/2013, 07/31/2013, 08/31/2013, 09/30/2013, 10/31/2013, 10/31/2015, 03/30/2016, 03/31/2016.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Canada
  • 제품 설명
    OneTouch Verio IQ Blood Glucose Monitoring System Kit; || One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; || One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. || Distributed by : LifeScan, Inc. || Milpitas, CA 95035 || for: LifeScan Europe || Division of Cilag GmBH International || 6300 Zug || Switzerland || Meter made in China. || Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood.
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • 제조사 주소
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA