Events

Retiro De Equipo (Recall) de Device Recall Access Immunoassay Systems enhanced AccuTnl Reagent

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Beckman Coulter Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    55554
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1883-2011
  • Fecha de inicio del evento
    2009-12-10
  • Fecha de publicación del evento
    2011-04-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91134
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Immunoassay method, troponin submit - Product Code MMI
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Lot Numbers: 911748; 913265; 913500; 915417; 915850; and 916721
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and country of Canada.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA