Class 2 Device Recall Access Total BhCG (BhCG) Assay

• Date Initiated by Firm: October 20, 2010
• Date Posted: March 21, 2011
• Recall Status: Terminated on September 02, 2014
• Recall Number: Z-1736-2011
• Recall Event ID: 57443
• 510(K)Number: K980173
• Product Classification: Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
• Product: Access Total BhCG (BhCG) Assay Part Number 33500 The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
• Code Information: All lot numbers
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: 714-993-5321
• Manufacturer Reason for Recall: Beckman Coulter has confirmed that non-reproducible falsely elevated test results may occur when using the Access Total BhCG assay. These elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range. The role of preanalytical factors in laboratory testing has been described in a variety of published literature.
• FDA Determined Cause: Pending
• Action: Beckman Coulter sent an Urgent Product Corrective Action letter dated November 11, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:. " Evaluate current laboratory protocols to ensure the necessary procedures are in place for identifying and mitigating falsely elevated test results. " Follow the sample handling instructions provided in the Access Total hCG Instruction for Use (IFU). " Review the enclosed pre-analytical sample handling information bulletins: 1. The Role of Preanalytical Factors in Chemistry and Immunoassay Testing (P/N A34880A). 2. Sample Handling Makes a Difference (P/N A28226A). " At the discretion of the laboratory director, any total hCG result that is questioned due to lack of clinical correlation should be repeated. NOTE: Due to the clinical utility of the Access Total hCG assay as a biomarker of pregnancy, Beckman Coulter feels it is unnecessary to require a review of all previously obtained Access Total hCG test results. The Access Total hCG assay is intended as a marker for pregnancy at the time of testing. A discrepant or questionable result would have been brought to the attention of the laboratory. The pregnancy status of a patient at this point, post testing, would be known to the patient and the physician. " Please share this information with your laboratory staff and your phlebotomy director and/or phlebotomy staff and retain this notification as part of your laboratory Quality System documentation. " Complete and return the enclosed response form within ten days so they can be assured that this important notification has been received. If you have any questions regarding this notification, please contact the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada
• Quantity in Commerce: 158,919 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Congo, Croatia, Czech Republic, Djibouti, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Zambia, Zimbabwe.
• 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 = JHI