Class 2 Device Recall Access Immunoassay Systems TOTAL hCG

• Date Initiated by Firm: March 05, 2009
• Date Posted: October 17, 2011
• Recall Status: Terminated on April 27, 2012
• Recall Number: Z-0050-2012
• Recall Event ID: 53046
• 510(K)Number: K023480
• Product Classification: Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
• Product: Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and plasma using the Access Immunoassay Systems.
• Code Information: Lot Numbers 824542 and 825652.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: Melina Cimler, Ph.D.; 714-993-5321
• Manufacturer Reason for Recall: The recall was initiated because Beckman Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recall communication was initiated on March 18, 2009 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter dated March 13, 2009 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems total hCG. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the reagent lot numbers 824542 and 825652, and discard any unused reagent packs. Customers were asked to review their historical records for low level quality control to ensure that the assay performance for the referenced lot numbers has been within their laboratory specifications. They were also asked to share the information with their laboratory staff and retain the letter for their Quality System documentation, and then complete and return the enclosed response form within 10 days so that they may be assured that consignees received the notification. Finally they were told to contact Customer Technical Support Center at 1-800-854-3633 in the US and Canada, or their local Beckman Coulter Representative with any questions.
• Quantity in Commerce: 14,764
• Distribution: Worldwide Distribution -- US, Algeria, Angola, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, canada, Chile, China, Colombia, Czech Republic, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Zambia.
• 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