Class 2 Device Recall Access Immunoassay Systems enhanced AccuTnl Reagent

• Date Initiated by Firm: December 10, 2009
• Date Posted: April 04, 2011
• Recall Status: Terminated on May 07, 2012
• Recall Number: Z-1883-2011
• Recall Event ID: 55554
• 510(K)Number: K010429 K021814
• Product Classification: Immunoassay method, troponin submit - Product Code MMI
• Product: 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.
• Code Information: Lot Numbers: 911748; 913265; 913500; 915417; 915850; and 916721
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: Clair K. ODonovan, Ph.D.; 714-961-4483
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Other
• 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
• Quantity in Commerce: 22,032 kits
• Distribution: Worldwide distribution: USA and country of 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