Events

Device Recall Sysmex 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
    74654
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2770-2016
  • 사례 시작날짜
    2016-07-01
  • 사례 출판 날짜
    2016-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148122
  • 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
    Stains, hematology - Product Code KQC
  • 원인
    There is a potential that fluorescent platelet (plt-f) and immature platelet fraction (ipf%) results performed using the recalled lots may exhibit lower than expected plt-f and ipf values. the issue may be recognized by a large discrepancy between the impedance platelet (plt-i) value and a false low plt-f value. in most cases, the falsely decreased plt-f results displayed a "plt abn scattergram" message with asterisks beside the results indicating the data is unreliable. in rare instances, platelet flags may be absent. the plt-i counts are unaffected. the plt-f is a reflex test used to confirm plt-i results due to flagging or low values. as such, the likely impact to patient results is low. affected results display a discrepancy between the plt-i and plt-f, with lower than expected plt-f results that do not match the patient's clinical picture.
  • 조치
    Sysmex sent a Product Notification Letter dated August 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. . Customers were instructed to cease use and discard the affected lots, and reply to Sysmex America, Inc. using the provided fax-back form. An updated Product Notification (Attachment 1) was mailed to all XN-Series customers on August 12, 2016 informing them of the additional recalled lots. This notification included the phone number for the Technical Assistance Center at 1-888-879-7639 in the U.S., and 1-888-679-7639 in Canada.

Device

Device Recall Sysmex
  • 모델명 / 제조번호(시리얼번호)
    Lot number A5053, Expiration date 12/21/2016 Lot number A5054, Expiration date 12/21/2016 Lot number A5041, Expiration date 9/2/2016 Lot number A5042, Expiration date 9/2/2016 Lot number A5044, Expiration date 10/2/2016 Lot number A5046, Expiration date 11/9/2016 Lot number A5047, Expiration date 11/17/2016 Lot number A5048, Expiration date 11/17/2016 Lot number A5049, Expiration date 11/26/2016 Lot number A5050, Expiration date 11/26/2016 Lot number A5055, Expiration date 12/24/2016
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic.
  • 제품 설명
    Fluorocell PLT reagent, Catalog #CD994563 || Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
  • 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