Class 2 Device Recall ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM 33340, 33345

• Date Initiated by Firm: February 06, 2010
• Date Posted: April 12, 2010
• Recall Status: Terminated on May 09, 2012
• Recall Number: Z-1318-2010
• Recall Event ID: 54729
• 510(K)Number: K010429 K021814
• Product Classification: immunoassay method, troponin subunit - Product Code MMI
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: Nora Zerounian; 714-961-3634
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 196,071 kits
• Distribution: Worldwide distribution: USA and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MMI