Events

Device Recall Sysmex pocH100i 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sysmex America 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
    65722
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0100-2014
  • 사례 시작날짜
    2013-05-15
  • 사례 출판 날짜
    2013-10-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119961
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
  • 조치
    The firm, Sysmex, sent a "Product Notification-FIELD CORRECTION" letter dated May 2013 to all customers in the U.S. and Canada on May 15, 2013 by U.S. Mail. The letter describes the product, problem and actions to be taken. The customers will be contacted by a Sysmex Service Representative within the following 90 days to schedule an appointment to replace the Printed Circuit Board (PCB) on the internal printer. The repair will be performed during an on-site service visit. The customers were instructed to, until the repair can be made, use the thermal printer for reporting results; to compare the sample identification, values and decimal points on the printout with the data on the LCD screen for accuracy. If you have any questions concerning this information, please email the Sysmex Technical Assistance Center (TAC). Simply click on email TAC button on the home page of the CRC, complete the form that appears and then click the submit to send your question to TAC. Sending an email to TAC is recommended for non-urgent requests. For urgent request, call the Technical Assistance Center at 1-888-879-7639.

Device

Device Recall Sysmex pocH100i
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 023-1861-8;  Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.
  • 제품 설명
    pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. || The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
  • Manufacturer
    Sysmex America Inc

Manufacturer

Sysmex America Inc
  • 제조사 주소
    Sysmex America Inc, 577 Aptakisic Rd, Lincolnshire IL 60069-4325
  • 제조사 모회사 (2017)
    Sysmex Corp.
  • Source
    USFDA