Events

Device Recall Access Immunoassay Systems enhanced AccuTnl Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    55554
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1883-2011
  • 사례 시작날짜
    2009-12-10
  • 사례 출판 날짜
    2011-04-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91134
  • 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
    Immunoassay method, troponin submit - Product Code MMI
  • 원인
    The recall was initiated after beckman coulter confirmed that under certain circumstances, the following assays may produce elevated values at the low end when run in conjunction with the enhanced access accu tnl assay (p/n a 78033): (1) access total bhcg (p/n 33500); (2) access hypersensitive htsh/fast htsh (p/n 33820); (3) access hfsh (p/n 33520). the issue can occur only when the assays are.
  • 조치
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated December 16, 2009 to all customers. The letter described the product, problem and actions to be taken. Beckman Coulter instructed the customers to do the following mitigation to reduce the risk of encountering an erroneous result: Systems with multiple reagent pipettors (UniCel Dxl 800 and 600; UniCel DxC 880i, 860i, 680i, and 660i): 1. Designate enhanced Access AccuTnl to a different reagent pipettor (s) than Access Total BhCG/Dil-hCG2, hTSH/Fast hTSH and hFSH. 2. Discard any open Access Total BhCG, hTSH/Fast hTSH and hFSH reagent packs 3. Calibrate Access Total BhCG, hTSH and hFSH using fresh reagent packs 4. Run QC following acceptable calibration curves. Proceed with operation following acceptable QC performance Systems without multiple reagent pipettors (Access, Access 2; SYNCHRON LXi 725, UniCel DxC 600i): 1. Discard any open Access Total BhCG, hTSH/Fast hTSH and hFSH reagent packs. 2. Calibrate Access Total BhCG, hTSH/Fast hTSH and hFSH using fresh reagent packs 3. Run QC following acceptable calibration curves. Ensure that controls and patient samples for Access Total BhCG/Dil-hCG2, hTSH/Fast hTSH and hFSH are not run immediately following enhanced Access AccuTnl controls or patient samples. For example, during routine QC runs, ensure that these assays are requested prior to enhanced Access AccuTnl. 4. Proceed with operation following acceptable QC performance. NOTE: An enhanced AccuTnl sample loaded with a system priority of STAT will interrupt routine Total BhCG/Dil-hCG2, hTSH/Fast hTSH and hFSH sample aspiration. Avoid loading enhanced AccuTnl sample aspiration. Avoid loading enhanced AccuTnl samples with a system priority of STAT during aspiration of Total BhCG/Dil-hCG2, hTSH/Fast hTSH and hFSH. Diagnostic test results should be interpreted in light of the clinical presentation of the patient, including: symptoms, clinical history, data from other

Device

Device Recall Access Immunoassay Systems enhanced AccuTnl Reagent
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 911748; 913265; 913500; 915417; 915850; and 916721
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and country of Canada.
  • 제품 설명
    Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803 || The Access Accu Tri assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin I determination aids in the risk stratification of patients with unstable angina coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA