Events

Device Recall STA System Control NP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Diagnostica Stago, 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
    61019
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1044-2012
  • 사례 시작날짜
    2011-08-23
  • 사례 출판 날짜
    2012-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107052
  • 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
    Plasma, coagulation control - Product Code GGN
  • 원인
    Factor viii quality control results are being recovered below the assigned ranges for sta system control n+p.
  • 조치
    Stago sent a recall letters via email dated August 23, 2011 to all affected customers . The letter identified the product, description of problem, and corrective actions to be taken. Customers were asked to immediately examine their inventory and follow the corrective actions provided. Customers were instructed to complete the response form attached to the letter. Because of incorrect manufacturer's instructions included in the initial letter another letter was emailed by the firm on August 30, 2011. For questions or technical assistance for updating the parameters please call the Diagnostica Stago 24 hour hotline at 1-800-725-0607.

Device

Device Recall STA System Control NP
  • 모델명 / 제조번호(시리얼번호)
    K9483518 D029396 Lot #106775
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution and USA (Nationwide) and including Canada
  • 제품 설명
    STA - System Control N + P || Product Usage: || The STA¿ -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STA¿brand name suitable to these reagents: -the Reagent 1 (STA¿-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase¿¿ time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA¿¿ -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase¿¿ time. Do not use the STA¿¿ -System Control N+P kit on STA Satellite¿ for the control of the APTT performed with the STA¿¿-rTT kit.
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

Diagnostica Stago, Inc.
  • 제조사 주소
    Diagnostica Stago, Inc., 5 Century Dr, Parsippany NJ 07054-4607
  • Source
    USFDA