Class 2 Device Recall Access Immunoassay Systems Estradiol

• Date Initiated by Firm: March 04, 2010
• Date Posted: November 23, 2010
• Recall Status: Terminated on May 07, 2012
• Recall Number: Z-0448-2011
• Recall Event ID: 55200
• 510(K)Number: K973743
• Product Classification: radioimmunoassay, estradiol - Product Code CHP
• Product: Access Immunoassay Systems Estradiol, Part Number: 33540 Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.
• Code Information: Lot Numbers: 913016 (exp. 6/20/2010), 915171 (exp. 10/30/2010), 917766 (exp. 12/21/2010)
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• Manufacturer Reason for Recall: The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF 33540) contains an incorrect raw material which may produce incorrect patient results.
• FDA Determined Cause: Other
• Action: A Product Corrective Action (PCA) letter dated March 17, 2010, with attached PCA Customer Response Form was sent to the affected customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of the three Access Estradiol Reagent lots; discard all remaining inventory of affected product; share this information with laboratory staff and retain the notification as part of their laboratory Quality System documentation, and complete and return the enclosed response form within 10 days via fax to 786-639-4000 or mail: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. The following product replacement contacts were provided: In the United States, please contact Client Services at 1-800-526-3821. In Canada, please contact Customer Service at 1-800-463-7828. Outside the United States and Canada, contact your local Beckman Coulter Representative. Questions and assistance could be obtained through Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.
• Quantity in Commerce: 20,209 units (5475 in US)
• Distribution: Worldwide distribution: USA and Internationally to: Algeria, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, El Salvador, France, Georgia, Germany, Ghana, Greece, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, United Kingdom, Venezuela, Vietnam, 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 = CHP