Events

Recall of Device Recall Access Immunoassay Systems enhanced AccuTnl Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55554
  • Event Risk Class
    Class 2
  • Event Number
    Z-1883-2011
  • Event Initiated Date
    2009-12-10
  • Event Date Posted
    2011-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91134
  • Notes / Alerts
    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.
  • Extra notes in the data
    Immunoassay method, troponin submit - Product Code MMI
  • Reason
    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.
  • Action
    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
  • Model / Serial
    Lot Numbers: 911748; 913265; 913500; 915417; 915850; and 916721
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and country of Canada.
  • Product Description
    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.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA