Events

Device Recall Sysmex StromatolyserIM (SIM220A) 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
    58916
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2797-2011
  • 사례 시작날짜
    2009-06-23
  • 사례 출판 날짜
    2011-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100607
  • 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
    Products, red-cell lysing products - Product Code GGK
  • 원인
    The affected lots of stromatolyser-im lysing reagent was found to be contaminated with pseudomonas bacteria, which resulted in rising imi channel background counts, increased false "platelet clump" flags and a strong sulfur-like odor when used on the xe-2100, xe-2100l and xe-5000 analyzers.
  • 조치
    Sysmex America, Inc. sent a "MEDICAL DEVICE RECALL" letter dated June 2009 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax at 800-218-2711. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the recall letter are directed to the Sysmex Technical Assistance Center at 1-888-879-7639. The firm sent a second notice to non-responding accounts on September 14, 2009. A copy of the June 26, 2009 recall letter and the fax back form were included with the letter. The customers were informed that Sysmex had not received their completed fax back form and were requested to respond to confirm the notification was received.

Device

Device Recall Sysmex StromatolyserIM (SIM220A)
  • 모델명 / 제조번호(시리얼번호)
    Catalog number SIM-220A, lot numbers C9010, C9011, C9013, C9014, C9015, C9016 and C9017
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.
  • 제품 설명
    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. || The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
  • Manufacturer
    Sysmex America, Inc.

Manufacturer

Sysmex America, Inc.
  • 제조사 주소
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • 제조사 모회사 (2017)
    Sysmex Corp.
  • Source
    USFDA