Events

Recall of Device Recall ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM 33340, 33345

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
    54729
  • Event Risk Class
    Class 2
  • Event Number
    Z-1318-2010
  • Event Initiated Date
    2010-02-06
  • Event Date Posted
    2010-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89075
  • 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 subunit - Product Code MMI
  • Reason
    The recall was initiated because beckman coulter has confirmed customer reports that different results have been obtained using the same patient samples on access/access 2 and unicel dxl platforms. values obtained with unicel dxl systems have been demonstrated to have a positive bias compared to values obtained with access or access 2 systems.
  • Action
    An "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated February 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers are recommended to immediately discontinue using AccuTnI Reagents and Calibrators on the UniCel DxI system until further notice. If this is not possible, the customers are directed to notify their stakeholders of the bias until further notice. The customers should complete, fax (786-639-4000) or mail the enclosed RESPONSE FORM. If consignees need assistance or have any questions regarding the notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.

Device

Device Recall ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM 33340, 33345
  • Model / Serial
    Lot Numbers:  716707, 720541,  720542,  721451,  721452,  722677,  722678,  821024,  821025,  821515, 821663, 823314, 823523, 823524, 823850, 825783, 825784, 826258, 826259, 827876, 828479, 829974, 831218, 850000,  850003, 850004, 850005, 850010, 850011, 850013, 908322, 908323, 908917, 908918, 909803, 909804, 911338, 911339, 911748, 912628, 912629, 913131, 913132, 913265, 913274, 913500, 913821, 914632, 915132, 915417, 915670, 915850, 916720, 916721,  916721A,  917611, 918460 Note: These Lot Numbers represent all reagent lots released to field that could be used in conjunction with Unicel DxI Access Immunoassay Systems.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Canada
  • Product Description
    Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345 || The intended use: The Access AccuTnI assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) 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 also aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute 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